Trial Outcomes & Findings for Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries (NCT NCT04198571)
NCT ID: NCT04198571
Last Updated: 2024-03-26
Results Overview
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the Infectious Disease Society of America \[IDSA\] guidelines a temperature of less than or equal to (\<=) 37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of greater than or equal to (\>=) 90 millimeters of mercury (mmHg), oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
COMPLETED
317 participants
Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
2024-03-26
Participant Flow
Participants hospitalized for Community Acquired Pneumonia (CAP) or Complicated Soft Skin Tissue Infections (cSSTI) and treated with four or more consecutive intravenous (IV) doses of Zinforo (ceftaroline fosamil) in a usual care setting on or before 31-May-2019, were included. Data was collected retrospectively from hospital records and evaluated over approximately 14 months of this study.
Participant milestones
| Measure |
Participants With CAP
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 milligram (mg) administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
132
|
|
Overall Study
COMPLETED
|
185
|
132
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to less than or equal to 65 years
|
90 Participants
n=185 Participants
|
83 Participants
n=132 Participants
|
173 Participants
n=317 Participants
|
|
Age, Customized
Greater than 65 years
|
95 Participants
n=185 Participants
|
49 Participants
n=132 Participants
|
144 Participants
n=317 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=185 Participants
|
55 Participants
n=132 Participants
|
131 Participants
n=317 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=185 Participants
|
77 Participants
n=132 Participants
|
186 Participants
n=317 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the Infectious Disease Society of America \[IDSA\] guidelines a temperature of less than or equal to (\<=) 37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of greater than or equal to (\>=) 90 millimeters of mercury (mmHg), oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Clinical Response
|
151 Participants
|
118 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Outcome measures
| Measure |
Participants With CAP
n=151 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=118 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time to Clinical Response
|
4 Days
Interval 0.0 to 18.0
|
4 Days
Interval 0.0 to 26.0
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Participants who achieved clinical cure were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Cure
|
115 Participants
|
72 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Time taken to achieve the clinical cure was reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=115 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=72 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time to Clinical Cure
|
7 Days
Interval 1.0 to 25.0
|
5 Days
Interval 1.0 to 28.0
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to adverse event (AE); drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Clinical Failure
|
34 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with CAP, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported.
Outcome measures
| Measure |
Participants With CAP
n=34 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants According to Reasons for Clinical Failure
Insufficient response
|
21 Participants
|
—
|
|
CAP: Number of Participants According to Reasons for Clinical Failure
Death due to index infection
|
7 Participants
|
—
|
|
CAP: Number of Participants According to Reasons for Clinical Failure
Death due to other
|
2 Participants
|
—
|
|
CAP: Number of Participants According to Reasons for Clinical Failure
Relapse or recurrence
|
2 Participants
|
—
|
|
CAP: Number of Participants According to Reasons for Clinical Failure
Unknown
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with cSSTI, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported.
Outcome measures
| Measure |
Participants With CAP
n=14 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Reasons for Clinical Failure
Treatment modification due to AE
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Reasons for Clinical Failure
Insufficient response
|
10 Participants
|
—
|
|
cSSTI: Number of Participants According to Reasons for Clinical Failure
Relapse or recurrence
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
Clinical stability was defined according to the IDSA guidelines as temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent. The time to achieve clinical stability was reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP Only: Time to Clinical Stability
|
3 Days
Interval 0.0 to 17.0
|
—
|
PRIMARY outcome
Timeframe: Baseline (before Day 1 of Zinforo treatment) till end of Zinforo treatment, up to maximum of 35 days [from the retrospective data evaluated in approximately 14 months of the study]Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
Clinical improvement was defined as improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none. The time to clinical improvement was reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP Only: Time to Clinical Improvement
|
3 Days
Interval 0.0 to 18.0
|
—
|
PRIMARY outcome
Timeframe: Within 4 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Participants with CAP who showed response within 4 days after treatment with Zinforo were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants With Early Response Within 4 Days
|
79 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 3 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area. Participants with cSSTI who showed response within 3 days after treatment with Zinforo were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants With Early Response Within 3 Days
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (before Day 1 of treatment) till end of treatment, up to maximum of 60 days [from the retrospective data evaluated in approximately 14 months of the study]Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The response to treatment in cSSTI participants was measured as \>=20% reduction from baseline in infection area.
Outcome measures
| Measure |
Participants With CAP
n=118 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area
|
3 Days
Interval 0.0 to 10.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The response to treatment in cSSTI participants was measured as cessation of spread of infection measured by total infection area.
Outcome measures
| Measure |
Participants With CAP
n=118 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area
|
2 Days
Interval 0.0 to 26.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Time taken for the cessation of spread of infection as measured by length and width of the infected area was reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=118 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width
|
2 Days
Interval 0.0 to 7.0
|
—
|
PRIMARY outcome
Timeframe: At discharge from hospital: any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Participants were categorized based on the discharge status in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Discharge Status
Died in the hospital
|
18 Participants
|
6 Participants
|
|
Number of Participants According to Discharge Status
Discharged to a nursing home or extended care facility
|
28 Participants
|
23 Participants
|
|
Number of Participants According to Discharge Status
Discharged to independent living (with or without support)
|
138 Participants
|
101 Participants
|
|
Number of Participants According to Discharge Status
Other
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who were re-hospitalized within 30 days of discharge were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Re-hospitalization Within 30 Days of Discharge
|
20 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to the vital status in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Vital Status Within 30 Days of Discharge
Participant is still alive
|
126 Participants
|
98 Participants
|
|
Number of Participants According to Vital Status Within 30 Days of Discharge
Participant is deceased
|
31 Participants
|
15 Participants
|
|
Number of Participants According to Vital Status Within 30 Days of Discharge
Unknown
|
28 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
MIC was defined as the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism. Participants were categorized as Yes, No or Unknown against being assessed for MIC.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment
Yes
|
23 Participants
|
28 Participants
|
|
Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment
No
|
161 Participants
|
94 Participants
|
|
Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment
Unknown
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of Index hospitalization till MIC assessment, any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Day of MIC assessment since the index hospitalization was reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Outcome measures
| Measure |
Participants With CAP
n=23 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=28 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Day of MIC Assessment Since Index Hospitalization
|
1 Days
Interval 0.0 to 10.0
|
4 Days
Interval -10.0 to 47.0
|
PRIMARY outcome
Timeframe: From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Pathogens for bacterial pneumonia were identified by blood, respiratory (e.g., sputum, bronchoalveolar lavage), or pleural effusion cultures and pathogens for cSSTI were identified blood or skin/soft tissue/bone/wound cultures. Number of participants with MIC of antibacterial drugs for pathogens isolated from samples were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=23 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=28 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens
MIC of ceftaroline for all isolated pathogens
|
5 Participants
|
7 Participants
|
|
Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens
MIC of oxacillin, vancomycin, linezolid, and daptomycin for Staphylococcus aureus
|
12 Participants
|
20 Participants
|
|
Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens
MIC of ceftriaxone for Methicillin-Susceptible Staphylococcus aureus (MSSA)
|
3 Participants
|
6 Participants
|
|
Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens
MIC of penicillin and ceftriaxone for Streptococcus pneumonia
|
10 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; hospitalization/prolongation of hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who had any medical conditions at the time of index hospitalization were reported in this outcome measure. Medical conditions that were considered included Human Immunodeficiency Virus (HIV) infection, alcohol abuse, cancer/malignancy, cerebrovascular disease, chronic dialysis within the past 30 days, chronic obstructive pulmonary disease, chronic renal disease, congestive heart failure, decompensated cirrhosis, diabetes mellitus, immunosuppressive disease, influenza, injection drug use, end stage liver disease, peripheral vascular disease, respiratory disease or any other relevant condition(s) or disease(s) that required chronic drug treatment. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Medical Conditions Presented at Index Hospitalization
|
147 Participants
|
99 Participants
|
PRIMARY outcome
Timeframe: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who had hospitalization for any reason, 3 months before the index hospitalization were reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization
|
34 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who had undergone surgical treatments, 3 months before to the index hospitalization were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization
|
5 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Number of participants according to therapies received in the 3 months prior to index hospitalization were reported in this outcome measure. One participant could receive more than one therapy.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Antimicrobial (e.g. antibiotics, antivirals)
|
47 Participants
|
56 Participants
|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Immunosuppressors/ immunomodulators
|
21 Participants
|
19 Participants
|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Anticoagulants
|
38 Participants
|
45 Participants
|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Non-steroid anti-inflammatory agents (NSAIs)
|
13 Participants
|
25 Participants
|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Home infusion therapy
|
3 Participants
|
2 Participants
|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
Home wound care provided by a medical professional
|
6 Participants
|
5 Participants
|
|
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
None
|
103 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Participants were categorized according to radiographic findings in the tests conducted for diagnosis of CAP infection in this outcome measure. One participant could have more than one radiographic finding.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Radiographic Findings in Tests for CAP
Pleural effusion
|
48 Participants
|
—
|
|
Number of Participants With Radiographic Findings in Tests for CAP
Other findings
|
30 Participants
|
—
|
|
Number of Participants With Radiographic Findings in Tests for CAP
Infiltrate
|
130 Participants
|
—
|
|
Number of Participants With Radiographic Findings in Tests for CAP
Consolidation
|
68 Participants
|
—
|
|
Number of Participants With Radiographic Findings in Tests for CAP
None of the above
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Participants were categorized according to triggering signs and symptoms at CAP diagnosis and recorded at index hospital admission were reported in this outcome measure. The observed signs and symptoms were dyspnea, tachypnea, or hypoxemia (oxygen \[O2\] saturation \< 90% on room air or partial pressure of oxygen (pO2) \< 60 mmHg), Fever (\>38 degree Celsius\[C\]oral; \> 38.5 degree C rectally or tympanically) or hypothermia (\< 35 degree C), White Blood Cell (WBC) count \> 10,000 cells/cubic millimeter(mm³) or \< 4,500 cells/mm³. One participant could have more than one signs or symptoms.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
New or increased cough
|
129 Participants
|
—
|
|
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Purulent sputum or change in sputum character
|
80 Participants
|
—
|
|
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Auscultatory findings consistent with pneumonia
|
138 Participants
|
—
|
|
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Dyspnea, tachypnea, or hypoxemia (O2 saturation < 90% on room air or pO2 < 60 mmHg)
|
148 Participants
|
—
|
|
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Fever (>38 degree C oral; > 38.5 degree C rectally or tympanically) or hypothermia (< 35 degree C)
|
127 Participants
|
—
|
|
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
WBC count > 10,000 cells/mm³ or < 4,500 cells/mm³
|
122 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
Number of participants diagnosed with severe CAP were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Severe CAP
|
128 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission(from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
In this outcome measure participants were categorized according to type of assessment used to assess CAP severity. Pneumonia severity index (PSI)/PORT score was used to calculate the probability of morbidity and mortality among participants with CAP. The score was used to predict the need for hospitalization in people with pneumonia. CURB- 65 was used to measure the confusion, blood urea, respiratory rate, blood pressure for the participants aged greater than or equal to 65 years. Multiple criteria to assess the severity of CAP exist. In this study severity was first globally assessed asking if a (any) criterion for severity of CAP would apply. In subsequent questions the details on the exact methods of the severity assessment were then asked. This included the information about PORT score / PSI, CURB-65 and recurrency of CAP.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
PORT Score / Pneumonia Severity Index
|
18 Participants
|
—
|
|
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
CURB-65
|
41 Participants
|
—
|
|
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
Other
|
15 Participants
|
—
|
|
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
None
|
71 Participants
|
—
|
|
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
Unknown
|
40 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The time taken (in days) taken to diagnose CAP in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission.
Outcome measures
| Measure |
Participants With CAP
n=99 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time of CAP Diagnosis at Index Hospitalization
|
1 Days
Interval 0.0 to 20.0
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
The number of participants with recurrent CAP infections were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Recurrent CAP Infections at Index Hospitalization
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
The number of participants were classified according to the various pathogens identified during CAP diagnosis in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Streptococcus pneumonia
|
44 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Escherichia coli
|
2 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Hemophilus influenza
|
3 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
H. Parainfluenza
|
1 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Legionella spp.
|
2 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Staphylococcus aureus
|
4 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Methicillin resistance Staphylococcus aureus
|
14 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Methicillin susceptible Staphylococcus. aureus
|
15 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Klebsiella pneumonia
|
3 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Other enterobacteria
|
2 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Pseudomonas aeruginosa
|
1 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Other microorganism
|
26 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
Unknown
|
15 Participants
|
—
|
|
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
None of the above
|
72 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Analysis population included all eligible participants whose data were retrieved from hospital medical records and assessed. This outcome measure was planned to be analyzed only in CAP participants.
The number of participants were classified according to the type of investigations performed for the microbiological CAP diagnosis and were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Sputum examination
|
33 Participants
|
—
|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Blood culture
|
39 Participants
|
—
|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Bronchoalveolar lavage or bronchial brush examination
|
10 Participants
|
—
|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Pleural fluid sample examination
|
4 Participants
|
—
|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Legionella antigen test in urine
|
5 Participants
|
—
|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Pneumococcal antigen test in urine
|
30 Participants
|
—
|
|
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
Other
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
In this outcome measure number of participants who had H1N1 Influenza virus determined using PCR were reported.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization
|
71 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
The number of participants according to the status of influenza vaccination were reported in this outcome measure, as vaccinated: Yes, No and Unknown.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization
Yes
|
32 Participants
|
—
|
|
CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization
No
|
64 Participants
|
—
|
|
CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization
Unknown
|
89 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
The number of participants according to the status of pneumococcal vaccination were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization
Yes
|
18 Participants
|
—
|
|
CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization
No
|
76 Participants
|
—
|
|
CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization
Unknown
|
91 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in CAP participants.
The number of participants were classified according to the biomarkers used for monitoring the state of CAP in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization
C-reactive protein (CRP)
|
182 Participants
|
—
|
|
CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization
Procalcitonin
|
73 Participants
|
—
|
|
CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization
Other biomarker
|
8 Participants
|
—
|
|
CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization
None of the above
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants classified according to the types of lesions involved in the cSSTI infection were reported in this outcome measure. One participant could have more than one type of lesion.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Abscess
|
45 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Cellulitis/fasciitis
|
82 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Post-traumatic wound
|
9 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Post-surgical wound
|
26 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Decubitus ulcer
|
5 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Diabetic leg ulcer
|
5 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Peripheral vascular disease ulcer
|
3 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Bite
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
Unknown
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
None of the above
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants were classified according to the body area involved in cSSTI are reported in this outcome measure. One participant could have more than one type of body area involvement.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Head
|
13 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Hand
|
3 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Upper extremities
|
14 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Lower extremities
|
74 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Thorax
|
19 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Abdomen
|
14 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Genitalia
|
9 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
Unknown
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants were classified according to the extent of skin that was affected with the infection in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
Less than (<) 5 centimeter square (cm^2)
|
12 Participants
|
—
|
|
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
5-10 cm^2
|
31 Participants
|
—
|
|
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
10-50 cm^2
|
34 Participants
|
—
|
|
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
Greater than (>) 50 cm^2
|
8 Participants
|
—
|
|
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
Unknown
|
47 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants were classified according to the level of infections in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Level of Infections at Index Hospitalization
Superficial
|
51 Participants
|
—
|
|
cSSTI: Number of Participants According to Level of Infections at Index Hospitalization
Deep incisional
|
51 Participants
|
—
|
|
cSSTI: Number of Participants According to Level of Infections at Index Hospitalization
Organ or space infection
|
20 Participants
|
—
|
|
cSSTI: Number of Participants According to Level of Infections at Index Hospitalization
Unknown
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants were classified according to the anatomical structures involved in the infections in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Epithelium
|
61 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Epidermis
|
92 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Dermis
|
88 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Subcutaneous fat
|
61 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Fascia
|
23 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Muscle
|
25 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
Unknown
|
23 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The time taken (in days) taken to diagnose cSSTI in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission.
Outcome measures
| Measure |
Participants With CAP
n=51 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time of cSSTI Diagnosis at Index Hospitalization
|
5 Days
Interval 0.0 to 100.0
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants that had recurrent cSSTI infections were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization
|
33 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants with triggering signs and symptoms during the cSSTI diagnosis were reported in this outcome measure. One participant could have more than one triggering signs and symptoms.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Purulent or seropurulent drainage/discharge
|
65 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Bullae
|
5 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Erythema
|
106 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Fluctuance
|
30 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Heat/localized warmth
|
90 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Pain/tenderness to palpitation
|
100 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Swelling/induration
|
78 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Skin necrosis
|
9 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Anesthesia
|
1 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Crackling
|
3 Participants
|
—
|
|
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
Induration beyond the erythematous area
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants were classified according to the systemic signs observed Including temperature greater than (\>) 30 degree Celsius, White blood cell count \>10,000 cells per millimeter cube(/mm3) or \<4,500/mm3 or immature neutrophils \>10%, septic shock, organ dysfunction and none of the above mentioned were reported. One participant could have more than one systemic sign.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
Temperature > 38 degree Celsius
|
77 Participants
|
—
|
|
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
White blood cell count
|
108 Participants
|
—
|
|
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
Septic shock
|
4 Participants
|
—
|
|
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
Organ dysfunction
|
13 Participants
|
—
|
|
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
None of the above
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
The number of participants classified according to the diagnostic tests conducted to diagnose cSSTI were reported in this outcome measure. One participant could have more than one type of diagnostic test.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Blood cultures
|
85 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Superficial swab and culture
|
40 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Needle aspiration
|
14 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Skin biopsy
|
7 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Surgical sample
|
22 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
X-ray
|
31 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Ultrasound
|
58 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Computed Tomography (CT)/ Magnetic Resonance Imaging (MRI)
|
35 Participants
|
—
|
|
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
Unknown/not performed
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. This outcome measure was planned to be analyzed only in cSSTI participants.
Pathogens identified by blood or skin/soft tissue/bone/wound cultures were recorded for participants with cSSTI.
Outcome measures
| Measure |
Participants With CAP
n=132 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Unknown
|
24 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Methicillin resistance Staphylococcus aureus
|
24 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Methicillin susceptible S. aureus (MSSA)
|
23 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Staphylococcus coagulase negative
|
8 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Streptococcus pneumonia
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Streptococcus pyogenes
|
4 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Streptococcus agalactiae
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Enterococcus faecalis
|
2 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Gram-negative bacilli
|
12 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Non-fermenting enterobacteria
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Other strict anaerobic bacteria
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Other microorganism
|
8 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
Mixed flora
|
1 Participants
|
—
|
|
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
None of the above
|
40 Participants
|
—
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to types of antibiotics that they received prior to Zinforo and reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Aminoglycoside
|
5 Participants
|
6 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Betalactam
|
17 Participants
|
20 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Carbapenem
|
12 Participants
|
4 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Ceftriaxone
|
45 Participants
|
10 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Cephalosporins
|
19 Participants
|
16 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Glycopeptide
|
4 Participants
|
18 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Macrolide
|
13 Participants
|
23 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Betalactam/Combination
|
36 Participants
|
6 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Quinolone
|
50 Participants
|
21 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Sulfonamide
|
37 Participants
|
10 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Clindamycin
|
1 Participants
|
4 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Other antibiotic agent
|
15 Participants
|
8 Participants
|
|
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
Unknown
|
17 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to the lines of therapy in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
First
|
134 Participants
|
87 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Second
|
85 Participants
|
58 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Third
|
40 Participants
|
24 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Fourth
|
20 Participants
|
13 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Fifth
|
5 Participants
|
5 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Sixth
|
2 Participants
|
3 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Seventh
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Eighth
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Nineth
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
Tenth
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to various routes of administration for pre-Zinforo treatment and were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
Oral
|
44 Participants
|
31 Participants
|
|
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
Intra-venous
|
111 Participants
|
73 Participants
|
|
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
Intra-muscular
|
7 Participants
|
0 Participants
|
|
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
Subcutaneous
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
Unknown
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Duration of Pre-Zinforo Treatment During Index Hospitalization
|
6 Days
Interval 0.0 to 45.0
|
8 Days
Interval 1.0 to 40.0
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time From Symptom Onset to First Dose of Pre-Zinforo Treatment
|
3 Days
Interval 0.0 to 20.0
|
2 Days
Interval 0.0 to 30.0
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to types of Pre-Zinforo treatment and were reported in this outcome measure. One participant could have more than one type of pre-Zinforo treatment.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization
Empiric
|
129 Participants
|
74 Participants
|
|
Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization
Definitive/Specific
|
13 Participants
|
19 Participants
|
|
Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization
Unknown
|
6 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization
|
2.02 Doses
Standard Deviation 0.93
|
2.18 Doses
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
The number of participants who had pre-Zinforo treatment modification were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization
|
91 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants classified according to the reasons for pre-Zinforo treatment modification were reported in this outcome measure. One participant could have more than one reason for treatment modification. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. One participant could have more than one reason for treatment modification.
Outcome measures
| Measure |
Participants With CAP
n=91 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=60 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
Other
|
14 Participants
|
16 Participants
|
|
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
Adverse event
|
5 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
Insufficient response
|
58 Participants
|
42 Participants
|
|
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
Possible interaction with other drug
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
Streamlining
|
29 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
Treatment response was defined according to the following criteria: CAP participants who demonstrated clinical stability (defined according to the Infectious Diseases Society of America \[IDSA\] guidelines as temperature of ≤37.8 C°, heart rate of ≤100 beats/min, respiratory rate of ≤24 breaths/min, systolic blood pressure of ≥90mmHg, oxygen saturation of ≥90%, and confusion/disorientation recorded as absent) and clinical improvement{defined as improvement of at least 1 of 4 symptoms present at baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none}. cSSTI participants: ≥20% reduction from baseline infection area and cessation of spread measured by total infection area. The number of participants were classified according to treatment response to pre-Zinforo treatment and were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization
Response
|
12 Participants
|
17 Participants
|
|
Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization
No response
|
89 Participants
|
14 Participants
|
|
Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization
Unknown
|
33 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The time (days) taken for modification from initial dose of pre-Zinforo treatment were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=91 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=60 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment
|
2 Days
Interval 0.0 to 13.0
|
3 Days
Interval 0.0 to 20.0
|
PRIMARY outcome
Timeframe: Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants with insufficient response to pre-Zinforo treatment were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=134 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=87 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization
|
58 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The duration of Zinforo treatment for CAP and cSSTI infections were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Duration of Zinforo Treatment During Index Hospitalization
|
7 Days
Interval 2.0 to 35.0
|
8 Days
Interval 2.0 to 60.0
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The time taken from admission to the administration of first dose of Zinforo was reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time From Admission to First Dose of Zinforo During Index Hospitalization
|
1 Days
Interval 0.0 to 36.0
|
1 Days
Interval 0.0 to 60.0
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The time taken for the symptom onset to the administration of first dose of Zinforo was reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization
|
6 Days
Interval 0.0 to 38.0
|
7 Days
Interval 0.0 to 64.0
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants classified according to the types of treatment for Zinforo were reported in this outcome measure. Types included empiric, definitive/specific and unknown. Empiric was defined as therapy administered to participants prior to the results of blood culture and susceptibility tests. Definitive was defined as therapy administered after the test results were received.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Types of Treatment for Zinforo
Empiric
|
138 Participants
|
84 Participants
|
|
Number of Participants According to Types of Treatment for Zinforo
Definitive/Specific
|
41 Participants
|
43 Participants
|
|
Number of Participants According to Types of Treatment for Zinforo
Unknown
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Daily Dose of Zinforo
|
1183.24 Milligrams
Standard Deviation 412.69
|
1239.39 Milligrams
Standard Deviation 402.43
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Infusions Administered Daily for Zinforo
|
2.28 Infusions
Standard Deviation 0.47
|
2.27 Infusions
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to the locations where Zinforo was administered were reported in this outcome measure. One participant could have more than one location of Zinforo administration.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Locations of Zinforo Administration
Intensive Care Unit (ICU)
|
66 Participants
|
11 Participants
|
|
Number of Participants According to Locations of Zinforo Administration
General ward
|
115 Participants
|
114 Participants
|
|
Number of Participants According to Locations of Zinforo Administration
At home
|
1 Participants
|
14 Participants
|
|
Number of Participants According to Locations of Zinforo Administration
Medical clinic
|
30 Participants
|
14 Participants
|
|
Number of Participants According to Locations of Zinforo Administration
Out-patient setting
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to Zinforo administration as monotherapy or combination therapy were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Administered Zinforo as Monotherapy or Combination Therapy
Monotherapy
|
56 Participants
|
78 Participants
|
|
Number of Participants Administered Zinforo as Monotherapy or Combination Therapy
Combination therapy
|
129 Participants
|
54 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Number of participants who received concomitant therapies along with Zinforo were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Receiving Concomitant Therapies Along With Zinforo
|
131 Participants
|
92 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to types of antibiotics received for index infection (CAP and cSSTI) after the Zinforo treatment were reported in this outcome measure. One participant could receive more than one type of antibiotic.
Outcome measures
| Measure |
Participants With CAP
n=99 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=75 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Aminoglycoside
|
9 Participants
|
3 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Betalactam
|
13 Participants
|
4 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Carbapenem
|
8 Participants
|
5 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Ceftriaxone
|
18 Participants
|
15 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Glycopeptide
|
7 Participants
|
5 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Macrolide
|
12 Participants
|
2 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Betalactam/Combination
|
27 Participants
|
12 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Quinolone
|
45 Participants
|
28 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Sulfonamide
|
12 Participants
|
2 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Clindamycin
|
32 Participants
|
21 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Other antibiotic agent
|
12 Participants
|
20 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Linezolid
|
0 Participants
|
2 Participants
|
|
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
Unknown
|
9 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to the lines of therapy for post-Zinforo treatment were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=99 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=75 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
First
|
1 Participants
|
2 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Second
|
45 Participants
|
46 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Third
|
40 Participants
|
20 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Fourth
|
51 Participants
|
21 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Fifth
|
26 Participants
|
11 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Sixth
|
25 Participants
|
5 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Seventh
|
5 Participants
|
5 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Eighth
|
8 Participants
|
2 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Nineth
|
3 Participants
|
4 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Tenth
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Eleventh
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
Twelfth
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: CAP (up to maximum of 102 days), cSSTI (up to maximum of 162 days)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to routes of administration for post-Zinforo treatment were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Route of Administration for Post-Zinforo Treatment
Oral
|
92 Participants
|
81 Participants
|
|
Number of Participants According to Route of Administration for Post-Zinforo Treatment
Intra-venous
|
112 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The duration in days from Zinforo treatment discontinuation to initiation of new treatment were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Duration From Zinforo Discontinuation to Initiation of New Treatment
|
1 Days
Interval 0.0 to 56.0
|
1 Days
Interval 0.0 to 36.0
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Doses Administered for Post Zinforo Treatment
|
11.05 Doses
Standard Deviation 14.82
|
16.38 Doses
Standard Deviation 21.81
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to the reasons for switching to post-Zinforo treatment were reported in this outcome measure. One participant could have more than one reason for switch.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
Lack of efficacy of previous treatment
|
39 Participants
|
9 Participants
|
|
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
Side effect of previous treatment
|
1 Participants
|
9 Participants
|
|
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
Results of susceptibility test/pathogen identification
|
26 Participants
|
14 Participants
|
|
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
Other
|
124 Participants
|
81 Participants
|
|
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
Unknown
|
14 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical response in CAP:participants demonstrating clinical stability(i.e.,according to IDSA guidelines:temperature of\<=37.8 degree Celsius,heart rate of \<=100 beats per minute,respiratory rate of \<=24 breaths per minute,systolic blood pressure of \>=90 mmHg,oxygen saturation of \>=90%,confusion/disorientation recorded as absent),clinical improvement(i.e.,improvement of at least 1 of 4 symptoms present at Baseline(i.e.,cough,dyspnea,pleuritic chest pain,sputum production)with worsening of none).Clinical response in cSSTI participants:\>=20% reduction from baseline infection area,cessation of spread measured by total infection area.Clinical failure for both CAP and cSSTI:any of the following:treatment modification due to AE;drug-drug interaction;insufficient response(followed by switch);death due to index infection;death due to other cause;relapse or recurrence. Number of participants classified according to treatment responses to post-Zinforo treatment reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Based on Treatment Response to Post-Zinforo Treatment
Clinical response
|
155 Participants
|
95 Participants
|
|
Number of Participants Based on Treatment Response to Post-Zinforo Treatment
Clinical failure
|
26 Participants
|
4 Participants
|
|
Number of Participants Based on Treatment Response to Post-Zinforo Treatment
Unknown
|
23 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to the locations in which post-Zinforo treatment was administered. One participant could have more than one location of administration.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
At home
|
64 Participants
|
70 Participants
|
|
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
ICU
|
70 Participants
|
1 Participants
|
|
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
General ward
|
86 Participants
|
42 Participants
|
|
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
Out-patient setting
|
9 Participants
|
16 Participants
|
|
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
Medical clinic
|
6 Participants
|
5 Participants
|
|
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
Other
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment
|
139 Participants
|
89 Participants
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. The number of participants were classified according to the reasons for clinical failure post-Zinforo treatment were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=26 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=4 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
Treatment modification due to adverse event
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
Insufficient response
|
14 Participants
|
1 Participants
|
|
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
Relapse/reoccurrence
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
Death due to infection
|
6 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
Death due to other
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 of admission of index hospitalization to discharge from hospital (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Duration of Index Hospitalization
|
12 Days
Interval 3.0 to 102.0
|
11 Days
Interval 3.0 to 162.0
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Duration in Intensive Care Unit
|
0 Days
Interval 0.0 to 46.0
|
0 Days
Interval 0.0 to 41.0
|
PRIMARY outcome
Timeframe: Post initiation of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who received renal replacement therapy after initiating treatment with Zinforo were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants were classified according to treatments received during index hospitalization were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Treatments Received During Index Hospitalization
Surgery related to the infection
|
5 Participants
|
37 Participants
|
|
Number of Participants According to Treatments Received During Index Hospitalization
Surgery unrelated to the infection
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Treatments Received During Index Hospitalization
Blood pressure support
|
44 Participants
|
12 Participants
|
|
Number of Participants According to Treatments Received During Index Hospitalization
Blood pressure support: Fluid resuscitation
|
32 Participants
|
7 Participants
|
|
Number of Participants According to Treatments Received During Index Hospitalization
Blood pressure support: Vasopressors
|
44 Participants
|
10 Participants
|
|
Number of Participants According to Treatments Received During Index Hospitalization
Blood pressure support: Invasive procedures
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Treatments Received During Index Hospitalization
None of the above
|
139 Participants
|
90 Participants
|
PRIMARY outcome
Timeframe: Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who received home-based care through a healthcare agency were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Who Received Home-Based Care Through a Healthcare Agency
|
16 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who had re-hospitalizations were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Re-hospitalizations
|
20 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
In this outcome measure, data is recorded for duration (in days) of re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization.
Outcome measures
| Measure |
Participants With CAP
n=20 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=13 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Duration of Re-hospitalizations
|
10.5 Days
Interval 1.0 to 39.0
|
9 Days
Interval 2.0 to 30.0
|
PRIMARY outcome
Timeframe: Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database. Here, ''Overall number of participants'' analyzed signifies number of participants evaluable for this outcome measure.
The number of participants were classified according to reasons for re-hospitalizations were reported in this outcome measure. Re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization.
Outcome measures
| Measure |
Participants With CAP
n=20 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=13 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants According to Reasons for Re-hozpitalization
For index infection
|
7 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Re-hozpitalization
For other reason
|
13 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who developed sepsis during index hospitalization were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Development of Sepsis During Index Hospitalization
|
38 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The qSOFA (also known as quickSOFA) was a bedside prompt that identified participants with suspected infection who are at greater risk for a poor outcome outside the intensive care unit (ICU). It used three criteria, assigning one point for low blood pressure Systolic blood pressure less than or equal to 100 millimeters of mercury (SBP\<=100 mmHg), high respiratory rate greater than or equal to (\>=) 22 breaths per min, or altered mentation (Glasgow coma scale\<15).
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted
|
74 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who required isolation were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Requiring Isolation
|
20 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition
Mechanical Ventilation
|
56 Participants
|
11 Participants
|
|
Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition
Oxygen Therapy
|
37 Participants
|
6 Participants
|
|
Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition
Parenteral Nutrition
|
17 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The number of participants who suffered from acute renal failure and necessitated renal replacement were reported in this outcome measure.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement
|
11 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Total Number of Doses of Zinforo Administered
|
18.96 Doses
Standard Deviation 11.05
|
23.29 Doses
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo
|
8.48 Doses
Standard Deviation 9.81
|
8.48 Doses
Standard Deviation 9.81
|
PRIMARY outcome
Timeframe: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Total Dose of Other Antibiotics Administered Post Zinforo Treatment
|
11.05 Milligrams
Standard Deviation 14.82
|
11.05 Milligrams
Standard Deviation 14.82
|
PRIMARY outcome
Timeframe: Day 1 of index hospitalization till discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)Population: Full analysis set included all participants with the respective type of infection who were eligible for the study and whose data was entered into the study database.
The cost of hospitalization of standard level hospitals was calculated as total hospital cost= total number of bed days \* per diem rate standard hospital general ward and the cost of hospitalization of advanced level hospitals was calculated as total number of bed days \* per diem rate advanced hospital.
Outcome measures
| Measure |
Participants With CAP
n=185 Participants
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 Participants
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Cost of Hospitalization
Standard hospital cost
|
9204.62 US dollars
Standard Deviation 12895.23
|
5196.2 US dollars
Standard Deviation 9070.35
|
|
Cost of Hospitalization
Advanced level cost
|
25408.01 US dollars
Standard Deviation 31704.58
|
20257.18 US dollars
Standard Deviation 36809.71
|
Adverse Events
Participants With CAP
Participants With cSSTI
Serious adverse events
| Measure |
Participants With CAP
n=185 participants at risk
Participants hospitalized for CAP and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
|
Participants With cSSTI
n=132 participants at risk
Participants hospitalized for cSSTI and treated with 4 or more IV doses of Zinforo on or before 31-May-2019 were observed during this retrospective chart review study. The recommended dose of Zinforo was 600 mg administered every 12 hours by intravenous infusion over 60 minutes for 5 to 14 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/185 • For adverse events: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI; For death: Day 1 of index hospitalization up to 30 days of discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
The adverse events attributed only to Zinforo treatment during index hospitalization as observed from medical records of participants were reported. There was no specific medical dictionary utilized to record adverse events.
|
0.76%
1/132 • For adverse events: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI; For death: Day 1 of index hospitalization up to 30 days of discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
The adverse events attributed only to Zinforo treatment during index hospitalization as observed from medical records of participants were reported. There was no specific medical dictionary utilized to record adverse events.
|
|
General disorders
Drug hypersensitivity
|
0.00%
0/185 • For adverse events: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI; For death: Day 1 of index hospitalization up to 30 days of discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
The adverse events attributed only to Zinforo treatment during index hospitalization as observed from medical records of participants were reported. There was no specific medical dictionary utilized to record adverse events.
|
0.76%
1/132 • For adverse events: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI; For death: Day 1 of index hospitalization up to 30 days of discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
The adverse events attributed only to Zinforo treatment during index hospitalization as observed from medical records of participants were reported. There was no specific medical dictionary utilized to record adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER