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Skin Infections, Bacterial clinical trials

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NCT ID: NCT01812382 Completed - Clinical trials for Skin Infections, Bacterial

Retapamulin Microdialysis Feasibility Study

Start date: April 2, 2014
Phase: Phase 1
Study type: Interventional

This feasibility study will allow for the determination of the in vivo recovery and time of dialysis to optimize a future thorough microdialysis study. This is a single session, open label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects. Three healthy subjects will be enrolled and complete the study procedures. Subjects will be admitted to the research unit on Day 1 and three microdialysis probes will be placed in the thigh of each subject prior to the start of the microdialysis procedure. After normal saline solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes. Saline perfusion will occur during the washout period. Microdialysis sampling will be done for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection will continue every 30 minutes for 4 hours. The approximate duration of study including follow-up is 4 days.

NCT ID: NCT01445600 Completed - Clinical trials for Skin Infections, Bacterial

ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

ALTARGOPMS
Start date: November 2012
Phase: N/A
Study type: Observational

This is an open label, multi-centre, non-interventional post-marketing surveillance.

NCT ID: NCT01209078 Completed - Clinical trials for Skin Infections, Bacterial

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

Start date: August 17, 2010
Phase: Phase 2
Study type: Interventional

This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

NCT ID: NCT01153880 Completed - Clinical trials for Skin Infections, Bacterial

United States Pharmacovigilence Retapamulin-Prescribing

Start date: December 2008
Phase: N/A
Study type: Observational

Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.

NCT ID: NCT00852540 Completed - Impetigo Clinical Trials

Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA

Start date: April 2009
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00684177 Completed - Clinical trials for Skin Infections, Bacterial

Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)

Start date: May 2008
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00555061 Completed - Clinical trials for Skin Infections, Bacterial

Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

Start date: September 2007
Phase: Phase 4
Study type: Interventional

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).

NCT ID: NCT00133874 Completed - Clinical trials for Skin Infections, Bacterial

Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

Start date: April 2005
Phase: Phase 3
Study type: Interventional

The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.