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

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