AUGMENTIN 1gm In Skin And Soft Tissue Infection
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Diseases, Infectious; Infection, Soft Tissue
Intervention: amoxicillin/clavulanate potassium 1gm (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue
infections
Clinical Details
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
GSK Investigational Site, Karachi, Pakistan
GSK Investigational Site, Lahore 54000, Pakistan
GSK Investigational Site, Lahore, Pakistan
Additional Information
Starting date: December 2004
Last updated: November 21, 2012
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