Official Title: “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 to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: amoxicillin/clavulanate potassium 1gm

Primary Measures

• Clinical response at 10 - 14 days post therapy

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)

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD, FACP Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00343135

Study ID Number: 103997

ClinicalTrials.gov Identifier: NCT00343135

Health Authority: Pakistan: Ministry of Health