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

Primary Purpose

Impetigo, Folliculitis, Secondarily Infected Eczema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Retapamulin (Altabax)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impetigo focused on measuring Eczema, Atopic dermatitis, Infection, Impetigo, Folliculitis

Eligibility Criteria

9 Months - 98 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients from 9 months of age up to 98 years of age.
  • Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus.
  • The patient, and if applicable the parent or guardian, is able to give informed consent
  • Females of child bearing potential have a negative urine pregnancy test.
  • Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.

Exclusion Criteria:

  • Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.
  • Subject who has been enrolled in a clinical trial within the last 30 days.
  • Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.
  • Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator
  • Subjects who have taken oral antibiotics within the last 7 days.
  • Subjects with known sensitivity to the study medication.
  • The subject is pregnant or breastfeeding

Sites / Locations

  • Houston Medical Center Building

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retapamulin ointment 1%

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.

Secondary Outcome Measures

Clinical Response at Follow up as Assessed by a Rating Scale
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.
Microbiologic Response at Follow up as Assessed by a Rating Scale
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."
Number of Participants Who Were a Therapeutic Success
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."
Erythema (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Erythema (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Purulence (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Purulence (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Crusting (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Crusting (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Tissue Edema (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Tissue Edema (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Pain (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Pain (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Wound Size at Baseline
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.
Wound Size at Follow up
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.
Number of Participants Reporting Any Adverse Event (AE)
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.

Full Information

First Posted
April 19, 2010
Last Updated
January 20, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01126268
Brief Title
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Official Title
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo, Folliculitis, Secondarily Infected Eczema, Minor Soft Tissue Infections
Keywords
Eczema, Atopic dermatitis, Infection, Impetigo, Folliculitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retapamulin ointment 1%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Retapamulin (Altabax)
Other Intervention Name(s)
Altabax
Intervention Description
Retapamulin ointment, applied topically twice daily for five days
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
Title
Clinical Response at Follow up as Assessed by a Rating Scale
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
Title
Microbiologic Response at Follow up as Assessed by a Rating Scale
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
Title
Number of Participants Who Were a Therapeutic Success
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
Title
Erythema (Sign and Symptom of Infection) at Baseline
Description
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame
baseline
Title
Erythema (Sign and Symptom of Infection) at Follow up
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
Title
Purulence (Sign and Symptom of Infection) at Baseline
Description
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame
baseline
Title
Purulence (Sign and Symptom of Infection) at Follow up
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
Title
Crusting (Sign and Symptom of Infection) at Baseline
Description
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame
baseline
Title
Crusting (Sign and Symptom of Infection) at Follow up
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
Title
Tissue Edema (Sign and Symptom of Infection) at Baseline
Description
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame
baseline
Title
Tissue Edema (Sign and Symptom of Infection) at Follow up
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
Title
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Description
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame
baseline
Title
Tissue Warmth (Sign and Symptom of Infection) at Follow up
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
Title
Pain (Sign and Symptom of Infection) at Baseline
Description
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time Frame
baseline
Title
Pain (Sign and Symptom of Infection) at Follow up
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
Title
Wound Size at Baseline
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
Title
Wound Size at Follow up
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
Title
Number of Participants Reporting Any Adverse Event (AE)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
98 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients from 9 months of age up to 98 years of age. Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus. The patient, and if applicable the parent or guardian, is able to give informed consent Females of child bearing potential have a negative urine pregnancy test. Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol. Exclusion Criteria: Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours. Subject who has been enrolled in a clinical trial within the last 30 days. Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated. Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator Subjects who have taken oral antibiotics within the last 7 days. Subjects with known sensitivity to the study medication. The subject is pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaide A Hebert, M.D.
Organizational Affiliation
University of Texas Health Science Center at Houston Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Medical Center Building
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28491950
Citation
Bohaty BR, Choi S, Cai C, Hebert AA. Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections. Int J Womens Dermatol. 2015 Mar 2;1(1):13-20. doi: 10.1016/j.ijwd.2014.12.002. eCollection 2015 Feb.
Results Reference
result

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

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