Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection (NCT01126268) | Clinical Trial Compass
CompletedPhase 4
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
United States38 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range
9 Months – 98 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
Timeframe: 6 to 8 days after treatment
Trial details
NCT IDNCT01126268
SponsorThe University of Texas Health Science Center, Houston