Skip to main content
OpenTrials
Completed

NCT Number: NCT00343135

AUGMENTIN 1gm In Skin And Soft Tissue Infection

Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Diseases, Infectious Infection, Soft Tissue Infections Skin Diseases Skin and Connective Tissue Diseases Soft Tissue Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Karachi, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

amoxicillin/clavulanate potassium 1gm

Drug

amoxicillin/clavulanate potassium 1gm

Primary outcomes

  1. Clinical response at 10 - 14 days post therapy

    Time frame: 10 - 14 days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 22, 2006
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.