Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01126268
Recruitment Status : Completed
First Posted : May 19, 2010
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Adelaide Hebert, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Impetigo
Folliculitis
Secondarily Infected Eczema
Minor Soft Tissue Infections
Intervention Drug: Retapamulin (Altabax)
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Retapamulin Ointment 1% Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 38
Completed 37
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
28
  73.7%
Between 18 and 65 years
6
  15.8%
>=65 years
4
  10.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
18.5  (25.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
27
  71.1%
Male
11
  28.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
Hide Description Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants whose wound cultures were positive for MRSA
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
5
2.Secondary Outcome
Title Clinical Response at Follow up as Assessed by a Rating Scale
Hide Description 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.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
1. Clinical success 23
2. Clinical improvement 11
3. No change 0
4. Clinical failure 1
5. Unable to determine 0
3.Secondary Outcome
Title Microbiologic Response at Follow up as Assessed by a Rating Scale
Hide Description 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.”
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
1. Microbiological eradication 1
2. Presumed microbiological eradication 23
3. Presumed microbiological improvement 10
4. Microbiological persistence 1
5. Presumed microbiological persistence 0
6. Unable to determine 0
7. New pathogen 0
8. Colonization 0
4.Secondary Outcome
Title Number of Participants Who Were a Therapeutic Success
Hide Description 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.”
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
23
5.Secondary Outcome
Title Erythema (Sign and Symptom of Infection) at Baseline
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 0
Minimal 10
Moderate 25
Severe 0
6.Secondary Outcome
Title Erythema (Sign and Symptom of Infection) at Follow up
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 9
Minimal 24
Moderate 2
Severe 0
7.Secondary Outcome
Title Purulence (Sign and Symptom of Infection) at Baseline
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 10
Minimal 14
Moderate 10
Severe 1
8.Secondary Outcome
Title Purulence (Sign and Symptom of Infection) at Follow up
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 34
Minimal 1
Moderate 0
Severe 0
9.Secondary Outcome
Title Crusting (Sign and Symptom of Infection) at Baseline
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 2
Minimal 8
Moderate 23
Severe 2
10.Secondary Outcome
Title Crusting (Sign and Symptom of Infection) at Follow up
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 25
Minimal 9
Moderate 1
Severe 0
11.Secondary Outcome
Title Tissue Edema (Sign and Symptom of Infection) at Baseline
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 3
Minimal 19
Moderate 13
Severe 0
12.Secondary Outcome
Title Tissue Edema (Sign and Symptom of Infection) at Follow up
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 19
Minimal 16
Moderate 0
Severe 0
13.Secondary Outcome
Title Tissue Warmth (Sign and Symptom of Infection) at Baseline
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 9
Minimal 20
Moderate 6
Severe 0
14.Secondary Outcome
Title Tissue Warmth (Sign and Symptom of Infection) at Follow up
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 21
Minimal 14
Moderate 0
Severe 0
15.Secondary Outcome
Title Pain (Sign and Symptom of Infection) at Baseline
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 8
Minimal 19
Moderate 8
Severe 0
16.Secondary Outcome
Title Pain (Sign and Symptom of Infection) at Follow up
Hide Description Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Absent 26
Minimal 9
Moderate 0
Severe 0
17.Secondary Outcome
Title Wound Size at Baseline
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: cm^2
14.43  (25.38)
18.Secondary Outcome
Title Wound Size at Follow up
Hide Description 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.
Time Frame 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: cm^2
4.31  (17.71)
19.Secondary Outcome
Title Number of Participants Reporting Any Adverse Event (AE)
Hide Description 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.
Time Frame baseline to 6 to 8 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of Retapamulin (Altabax)
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description:
Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
4
Time Frame 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Retapamulin Ointment 1%
Hide Arm/Group Description Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
All-Cause Mortality
Retapamulin Ointment 1%
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Retapamulin Ointment 1%
Affected / at Risk (%) # Events
Total   0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Retapamulin Ointment 1%
Affected / at Risk (%) # Events
Total   4/38 (10.53%)    
General disorders   
Cough *  1/38 (2.63%)  1
Infections and infestations   
Upper respiratory infection *  1/38 (2.63%)  1
Skin and subcutaneous tissue disorders   
Burning at Retapamulin (Altabax) application site *  1/38 (2.63%)  1
Furuncle *  1/38 (2.63%)  1
Rash at site other than the Retapamulin (Altabax) application site *  1/38 (2.63%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Adelaide A Hebert
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 500-8339
Responsible Party: Adelaide Hebert, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01126268     History of Changes
Other Study ID Numbers: HSC-MS-09-0650
First Submitted: April 19, 2010
First Posted: May 19, 2010
Results First Submitted: December 14, 2015
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016