AUGMENTIN 1gm In Skin And Soft Tissue Infection
Overview
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
Full Title of Study: “An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2005
Interventions
- Drug: amoxicillin/clavulanate potassium 1gm
- amoxicillin/clavulanate potassium 1gm
Arms, Groups and Cohorts
- Experimental: ARM 1
Clinical Trial Outcome Measures
Primary Measures
- Clinical response at 10 – 14 days post therapy
- Time Frame: 10 – 14 days
Secondary Measures
- Clinical response at on-therapy evaluation visit (2 – 4 days following initiation of therapy and 48 – 96 hours post therapy) Bacteriological response at (2 – 4 days following initiation of therapy, 48 – 96 hours post therapy, 10 – 14 days post therapy)
- Time Frame: 2 – 4 days
Participating in This Clinical Trial
Inclusion Criteria
- having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis) – has given freely documented consent. Exclusion Criteria:
- antibiotics – have renal or hepatic insufficiency – systemic toxicity – pregnancy – lactation – hypersensitivity to penicillin or Beta-lactam antibiotics
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- GlaxoSmithKline
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- GSK Clinical Trials, Study Director, GlaxoSmithKline
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.