Phase 4
N=38
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Impetigo · Folliculitis · Secondarily Infected Eczema · Minor Soft Tissue Infections
Bottom Line
View on ClinicalTrials.gov: NCT01126268 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Retapamulin (Altabax) (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| SECONDARY Clinical Response at Follow up as Assessed by a Rating Scale |
23; 11; 0; 1; 0 | — |
| SECONDARY Microbiologic Response at Follow up as Assessed by a Rating Scale |
1; 23; 10; 1; 0; 0 | — |
| SECONDARY Number of Participants Who Were a Therapeutic Success |
23 | — |
| SECONDARY Erythema (Sign and Symptom of Infection) at Baseline |
0; 10; 25; 0 | — |
| SECONDARY Erythema (Sign and Symptom of Infection) at Follow up |
9; 24; 2; 0 | — |
| SECONDARY Purulence (Sign and Symptom of Infection) at Baseline |
10; 14; 10; 1 | — |
| SECONDARY Purulence (Sign and Symptom of Infection) at Follow up |
34; 1; 0; 0 | — |
| SECONDARY Crusting (Sign and Symptom of Infection) at Baseline |
2; 8; 23; 2 | — |
| SECONDARY Crusting (Sign and Symptom of Infection) at Follow up |
25; 9; 1; 0 | — |
| SECONDARY Tissue Edema (Sign and Symptom of Infection) at Baseline |
3; 19; 13; 0 | — |
| SECONDARY Tissue Edema (Sign and Symptom of Infection) at Follow up |
19; 16; 0; 0 | — |
| SECONDARY Tissue Warmth (Sign and Symptom of Infection) at Baseline |
9; 20; 6; 0 | — |
| SECONDARY Tissue Warmth (Sign and Symptom of Infection) at Follow up |
21; 14; 0; 0 | — |
| SECONDARY Pain (Sign and Symptom of Infection) at Baseline |
8; 19; 8; 0 | — |
| SECONDARY Pain (Sign and Symptom of Infection) at Follow up |
26; 9; 0; 0 | — |
| SECONDARY Wound Size at Baseline |
14.43 | — |
| SECONDARY Wound Size at Follow up |
4.31 | — |
| SECONDARY Number of Participants Reporting Any Adverse Event (AE) |
4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01126268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.