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.

Recruitment status

COMPLETED

Target enrollment

317 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)

Results posted on

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 31 deaths

Participants With cSSTI

Serious events: 2 serious events
Other events: 0 other events
Deaths: 15 deaths

Serious adverse events

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

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Phone: 1-800-718-1021

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