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Last Updated: October 21, 2019

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CLINICAL TRIALS PROFILE FOR RETAPAMULIN

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Clinical Trials for Retapamulin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00539994 Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus Completed GlaxoSmithKline Phase 2 2007-09-01 This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.
NCT00555061 Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. Completed GlaxoSmithKline Phase 4 2007-09-01 A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
NCT00684177 Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL) Completed GlaxoSmithKline Phase 3 2008-05-01 The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.
NCT00852540 Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA Completed GlaxoSmithKline Phase 3 2009-04-01 The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.
NCT00852540 Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA Completed Stiefel, a GSK Company Phase 3 2009-04-01 The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.
NCT00856089 Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization Withdrawn GlaxoSmithKline Phase 4 2009-05-01 The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
NCT00856089 Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization Withdrawn Tulane University School of Medicine Phase 4 2009-05-01 The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Retapamulin

Condition Name

Condition Name for Retapamulin
Intervention Trials
Skin Infections, Bacterial 6
Impetigo 3
Methicillin-Resistant Staphylococcus Aureus 3
Secondarily Infected Eczema 1
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Condition MeSH

Condition MeSH for Retapamulin
Intervention Trials
Bacterial Infections 7
Skin Diseases, Infectious 6
Staphylococcal Infections 4
Impetigo 4
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Clinical Trial Locations for Retapamulin

Trials by Country

Trials by Country for Retapamulin
Location Trials
United States 59
South Africa 3
Argentina 3
Germany 2
Brazil 2
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Trials by US State

Trials by US State for Retapamulin
Location Trials
California 5
Florida 4
Texas 4
New York 4
Ohio 3
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Clinical Trial Progress for Retapamulin

Clinical Trial Phase

Clinical Trial Phase for Retapamulin
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Retapamulin
Clinical Trial Phase Trials
Completed 12
Withdrawn 2
Not yet recruiting 1
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Clinical Trial Sponsors for Retapamulin

Sponsor Name

Sponsor Name for Retapamulin
Sponsor Trials
GlaxoSmithKline 11
Stiefel, a GSK Company 1
Ferrer Internacional S.A. 1
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Sponsor Type

Sponsor Type for Retapamulin
Sponsor Trials
Industry 13
Other 7
U.S. Fed 2
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