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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

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, FACP, 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: 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)

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 Clinical Trials Call Center, Lahore 54000, Pakistan

GSK Clinical Trials Call Center, Karachi 74000, Pakistan

Additional Information

Starting date: December 2004
Last updated: March 4, 2008

Page last updated: June 20, 2008

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