AUGMENTIN 1gm In Skin And Soft Tissue Infection
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection, Soft Tissue
Intervention: amoxicillin/clavulanate potassium 1gm (Drug)
Phase: Phase 4
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, FACP, Study Director, Affiliation: GlaxoSmithKline
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Clinical response at 10 - 14 days post therapy
Secondary outcome: 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)
Minimum age: 12 Years.
Maximum age: N/A.
- having diagnosed uncomplicated soft tissue infection (e. g furuncle, cellulitis)
- has given freely documented consent.
- have renal or hepatic insufficiency
- systemic toxicity
- hypersensitivity to penicillin or Beta-lactam antibiotics
Locations and Contacts
GSK Clinical Trials Call Center, Lahore 54000, Pakistan
GSK Clinical Trials Call Center, Karachi 74000, Pakistan
Starting date: December 2004
Last updated: March 4, 2008