Trial Outcomes & Findings for Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection (NCT NCT01126268)
NCT ID: NCT01126268
Last Updated: 2016-02-17
Results Overview
Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.
COMPLETED
PHASE4
38 participants
6 to 8 days after treatment
2016-02-17
Participant Flow
Participant milestones
| Measure |
Retapamulin Ointment 1% Group
Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
|
|---|---|
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Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Retapamulin Ointment 1% Group
Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
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|---|---|
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Overall Study
Adverse Event
|
1
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Baseline Characteristics
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Baseline characteristics by cohort
| Measure |
Retapamulin Ointment 1%
n=38 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
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Age, Categorical
<=18 years
|
28 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Age, Continuous
|
18.5 years
STANDARD_DEVIATION 25.66 • n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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38 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: Participants whose wound cultures were positive for MRSA
Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=7 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
|
5 participants
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SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Clinical Response at Follow up as Assessed by a Rating Scale
1. Clinical success
|
23 participants
|
|
Clinical Response at Follow up as Assessed by a Rating Scale
2. Clinical improvement
|
11 participants
|
|
Clinical Response at Follow up as Assessed by a Rating Scale
3. No change
|
0 participants
|
|
Clinical Response at Follow up as Assessed by a Rating Scale
4. Clinical failure
|
1 participants
|
|
Clinical Response at Follow up as Assessed by a Rating Scale
5. Unable to determine
|
0 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure."
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
1. Microbiological eradication
|
1 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
2. Presumed microbiological eradication
|
23 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
3. Presumed microbiological improvement
|
10 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
4. Microbiological persistence
|
1 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
5. Presumed microbiological persistence
|
0 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
6. Unable to determine
|
0 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
7. New pathogen
|
0 participants
|
|
Microbiologic Response at Follow up as Assessed by a Rating Scale
8. Colonization
|
0 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures."
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
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Number of Participants Who Were a Therapeutic Success
|
23 participants
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SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Erythema (Sign and Symptom of Infection) at Baseline
Absent
|
0 participants
|
|
Erythema (Sign and Symptom of Infection) at Baseline
Minimal
|
10 participants
|
|
Erythema (Sign and Symptom of Infection) at Baseline
Moderate
|
25 participants
|
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Erythema (Sign and Symptom of Infection) at Baseline
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Erythema (Sign and Symptom of Infection) at Follow up
Absent
|
9 participants
|
|
Erythema (Sign and Symptom of Infection) at Follow up
Minimal
|
24 participants
|
|
Erythema (Sign and Symptom of Infection) at Follow up
Moderate
|
2 participants
|
|
Erythema (Sign and Symptom of Infection) at Follow up
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Purulence (Sign and Symptom of Infection) at Baseline
Absent
|
10 participants
|
|
Purulence (Sign and Symptom of Infection) at Baseline
Minimal
|
14 participants
|
|
Purulence (Sign and Symptom of Infection) at Baseline
Moderate
|
10 participants
|
|
Purulence (Sign and Symptom of Infection) at Baseline
Severe
|
1 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Purulence (Sign and Symptom of Infection) at Follow up
Absent
|
34 participants
|
|
Purulence (Sign and Symptom of Infection) at Follow up
Minimal
|
1 participants
|
|
Purulence (Sign and Symptom of Infection) at Follow up
Moderate
|
0 participants
|
|
Purulence (Sign and Symptom of Infection) at Follow up
Severe
|
0 participants
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SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Crusting (Sign and Symptom of Infection) at Baseline
Absent
|
2 participants
|
|
Crusting (Sign and Symptom of Infection) at Baseline
Minimal
|
8 participants
|
|
Crusting (Sign and Symptom of Infection) at Baseline
Moderate
|
23 participants
|
|
Crusting (Sign and Symptom of Infection) at Baseline
Severe
|
2 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Crusting (Sign and Symptom of Infection) at Follow up
Absent
|
25 participants
|
|
Crusting (Sign and Symptom of Infection) at Follow up
Minimal
|
9 participants
|
|
Crusting (Sign and Symptom of Infection) at Follow up
Moderate
|
1 participants
|
|
Crusting (Sign and Symptom of Infection) at Follow up
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Tissue Edema (Sign and Symptom of Infection) at Baseline
Absent
|
3 participants
|
|
Tissue Edema (Sign and Symptom of Infection) at Baseline
Minimal
|
19 participants
|
|
Tissue Edema (Sign and Symptom of Infection) at Baseline
Moderate
|
13 participants
|
|
Tissue Edema (Sign and Symptom of Infection) at Baseline
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Tissue Edema (Sign and Symptom of Infection) at Follow up
Absent
|
19 participants
|
|
Tissue Edema (Sign and Symptom of Infection) at Follow up
Minimal
|
16 participants
|
|
Tissue Edema (Sign and Symptom of Infection) at Follow up
Moderate
|
0 participants
|
|
Tissue Edema (Sign and Symptom of Infection) at Follow up
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Absent
|
9 participants
|
|
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Minimal
|
20 participants
|
|
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Moderate
|
6 participants
|
|
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Absent
|
21 participants
|
|
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Minimal
|
14 participants
|
|
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Moderate
|
0 participants
|
|
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Pain (Sign and Symptom of Infection) at Baseline
Absent
|
8 participants
|
|
Pain (Sign and Symptom of Infection) at Baseline
Minimal
|
19 participants
|
|
Pain (Sign and Symptom of Infection) at Baseline
Moderate
|
8 participants
|
|
Pain (Sign and Symptom of Infection) at Baseline
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Pain (Sign and Symptom of Infection) at Follow up
Absent
|
26 participants
|
|
Pain (Sign and Symptom of Infection) at Follow up
Minimal
|
9 participants
|
|
Pain (Sign and Symptom of Infection) at Follow up
Moderate
|
0 participants
|
|
Pain (Sign and Symptom of Infection) at Follow up
Severe
|
0 participants
|
SECONDARY outcome
Timeframe: baselinePopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Wound Size at Baseline
|
14.43 cm^2
Standard Deviation 25.38
|
SECONDARY outcome
Timeframe: 6 to 8 days after treatmentPopulation: All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=35 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Wound Size at Follow up
|
4.31 cm^2
Standard Deviation 17.71
|
SECONDARY outcome
Timeframe: baseline to 6 to 8 days after treatmentPopulation: All participants who received at least 1 dose of Retapamulin (Altabax)
AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.
Outcome measures
| Measure |
Retapamulin Ointment 1%
n=38 Participants
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Number of Participants Reporting Any Adverse Event (AE)
|
4 participants
|
Adverse Events
Retapamulin Ointment 1%
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Retapamulin Ointment 1%
n=38 participants at risk
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
|
|---|---|
|
Skin and subcutaneous tissue disorders
Burning at Retapamulin (Altabax) application site
|
2.6%
1/38 • Number of events 1 • 5 days
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
1/38 • Number of events 1 • 5 days
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
2.6%
1/38 • Number of events 1 • 5 days
|
|
General disorders
Cough
|
2.6%
1/38 • Number of events 1 • 5 days
|
|
Skin and subcutaneous tissue disorders
Rash at site other than the Retapamulin (Altabax) application site
|
2.6%
1/38 • Number of events 1 • 5 days
|
Additional Information
Dr. Adelaide A Hebert
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place