Trial Outcomes & Findings for Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections (NCT NCT00261807)
NCT ID: NCT00261807
Last Updated: 2022-01-27
Results Overview
Clinical response was assessed by measuring impact of therapy on certain wound parameters. Specifically Erythema, Induration/Swelling, Suppuration, were recorded visually and WBC Counts were considered improved if \<12,000/cu mm. The clinical response was documented as: 1. CURE (resolution of clinical signs and symptoms and no additional need for gram-positive antibiotic therapy. 2. IMPROVED (partial resolution of clinical signs and symptoms (although patient's clinical status had not completely returned to preinfection baseline but infectious process had been controlled , no additional gram-positive antibiotic therapy was needed; 3. FAILURE (no response, worsening of clinical signs and symptoms of infection; or additional gram-positive antibiotic therapy was needed ); 4. UNABLE TO EVALUATE (unable to determine response; e.g., no evaluation performed at specified time points, or administration of non-study antibiotics effective against study pathogen).
COMPLETED
NA
25 participants
The clinical response was measured at the end of treatment (7-14 days)
2022-01-27
Participant Flow
Patients were enrolled from an academic inpatient center which sees about 200 severe soft tissue patients every year. Subjects were enrolled from (2005-2008).
Patients with necrotizing skin infections were screened for the study. A total of 25 subjects were enrolled. Patients were excluded if they had renal failure, high CPK, or myoglobln or if they did not meet the inclusion exculsion criteria. Also, if patient was unable to give consent and family was not present.
Participant milestones
| Measure |
Single ARM Study
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Single ARM Study
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections
Baseline characteristics by cohort
| Measure |
Single ARM Study
n=25 Participants
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
WBC Counts,Fever and Wound Appearance.
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The clinical response was measured at the end of treatment (7-14 days)Population: Of the total 25 patients enrolled, 18 were measured as described in Baseline Population
Clinical response was assessed by measuring impact of therapy on certain wound parameters. Specifically Erythema, Induration/Swelling, Suppuration, were recorded visually and WBC Counts were considered improved if \<12,000/cu mm. The clinical response was documented as: 1. CURE (resolution of clinical signs and symptoms and no additional need for gram-positive antibiotic therapy. 2. IMPROVED (partial resolution of clinical signs and symptoms (although patient's clinical status had not completely returned to preinfection baseline but infectious process had been controlled , no additional gram-positive antibiotic therapy was needed; 3. FAILURE (no response, worsening of clinical signs and symptoms of infection; or additional gram-positive antibiotic therapy was needed ); 4. UNABLE TO EVALUATE (unable to determine response; e.g., no evaluation performed at specified time points, or administration of non-study antibiotics effective against study pathogen).
Outcome measures
| Measure |
Single ARM Study
n=18 Participants
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Erythema-EOT · Cure
|
16 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Erythema-EOT · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Erythema-EOT · Failure
|
2 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Erythema-EOT · Unable to Evaluate
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Induration EOT · Cure
|
17 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Induration EOT · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Induration EOT · Failure
|
1 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Induration EOT · Unable to Evaluate
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Suppuration-EOT · Cure
|
13 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Suppuration-EOT · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Suppuration-EOT · Failure
|
5 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
Suppuration-EOT · Unable to Evaluate
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
WBC Counts EOT · Cure
|
18 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
WBC Counts EOT · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
WBC Counts EOT · Failure
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT)
WBC Counts EOT · Unable to Evaluate
|
0 Participants
|
PRIMARY outcome
Timeframe: The clinical response was measured at Test of Cure (3-28 days post end of treatment)Population: Of the total 25 patients enrolled, 18 were measured as described in Baseline Population
Clinical response was assessed by measuring impact of therapy on certain wound parameters. Specifically Erythema, Induration/Swelling, Suppuration, were recorded visually and WBC Counts were considered improved if \<12,000/cu mm. The clinical response was documented as: 1. CURE (resolution of clinical signs and symptoms and no additional need for gram-positive antibiotic therapy. 2. IMPROVED (partial resolution of clinical signs and symptoms (although patient's clinical status had not completely returned to preinfection baseline but infectious process had been controlled , no additional gram-positive antibiotic therapy was needed; 3. FAILURE (no response, worsening of clinical signs and symptoms of infection; or additional gram-positive antibiotic therapy was needed ); 4. UNABLE TO EVALUATE (unable to determine response; e.g., no evaluation performed at specified time points, or administration of non-study antibiotics effective against study pathogen).
Outcome measures
| Measure |
Single ARM Study
n=18 Participants
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Erythema-TOC · Cure
|
18 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Erythema-TOC · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Erythema-TOC · Failure
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Erythema-TOC · Unable to Evaluate
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Induration TOC · Cure
|
18 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Induration TOC · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Induration TOC · Failure
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Induration TOC · Unable to Evaluate
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Suppuration · Cure
|
18 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Suppuration · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Suppuration · Failure
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
Suppuration · Unable to Evaluate
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
WBC Counts-TOC · Cure
|
18 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
WBC Counts-TOC · Improved
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
WBC Counts-TOC · Failure
|
0 Participants
|
|
Clinical Response to High Dose Daptomycin Therapy at Test of Cure (TOC)
WBC Counts-TOC · Unable to Evaluate
|
0 Participants
|
SECONDARY outcome
Timeframe: The microbiologicall response will be measured at the end of treatment (7-14 days) and Test of Cure (TOC) (3-28 days)Population: Of the 25 patients enrolled in study, 23 were analyzed for Microbiological response at end of treatment and only 18 analyzed at Test of Cure visit (2 lost to follow up, 2 received additional antibiotics for infections at other sites (unrelated to primary infection) and 1 patient died during the study period)
Bacterial cultures were obtained in all patients and repeated if the patient had a second surgical intervention. The microbiological responses were documented as follows: 1. DOCUMENTED ERADICATED: the baseline infecting pathogen was absent at end of treatment as determined by a negative culture. 2. PRESUMED ERADICATED: The baseline infection was presumed absent at the end of treatment as determined that there was "nothing to culture". 3. DOCUMENTED PERSISTENT: The baseline infecting pathogen was present at the end of treatment.
Outcome measures
| Measure |
Single ARM Study
n=23 Participants
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
End of Therapy · Documented Eradicated
|
0 Participants
|
|
Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
End of Therapy · Presumed Eradicated
|
23 Participants
|
|
Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
End of Therapy · Documented Persistent
|
0 Participants
|
|
Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
Test of Cure · Documented Eradicated
|
0 Participants
|
|
Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
Test of Cure · Presumed Eradicated
|
18 Participants
|
|
Microbiological Response to High Dose Daptomycin Therapy at End of Treatment (EOT) and Test of Cure (TOC)
Test of Cure · Documented Persistent
|
0 Participants
|
Adverse Events
Single ARM Study
Serious adverse events
| Measure |
Single ARM Study
n=25 participants at risk
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Infections and infestations
Gram Negative Rod Bacteremia
|
4.0%
1/25 • Number of events 1 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Single ARM Study
n=25 participants at risk
It was a single arm study with daptomycin use at a higher dose for patients with severe skin and soft tissue infections.
Daptomycin 6mg/kg/day
|
|---|---|
|
Infections and infestations
C. difficle infection
|
4.0%
1/25 • Number of events 1 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
|
Infections and infestations
Vaginal Yeast Infection
|
8.0%
2/25 • Number of events 2 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
3/25 • Number of events 3 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Number of events 1 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Swelling
|
4.0%
1/25 • Number of events 1 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
|
General disorders
High CPK
|
4.0%
1/25 • Number of events 1 • From initiation of study until Test of Cure (defined as 3-28 days from end of treatment, which was an average duration of 9.4 days of therapy, with a range between 7 and 14 days)
Events described consistent with clinicaltrials.gov definitions
|
Additional Information
Dr. Manjari Joshi
U. of Maryland Medical Systems, R Adams Cowley Shock Trauma Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place