AUGMENTIN 1gm In Skin And Soft Tissue Infection

Phase 4

Completed

• Conditions: Infection, Soft Tissue; Skin Diseases, Infectious
• Interventions: Drug: amoxicillin/clavulanate potassium 1gm

• Registration Number: NCT00343135
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2006-06-20
• Study First Submitted QC: 2006-06-20
• Study First Posted: 2006-06-22
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
• has given freely documented consent.

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Exclusion Criteria

• antibiotics
• have renal or hepatic insufficiency
• systemic toxicity
• pregnancy
• lactation
• hypersensitivity to penicillin or Beta-lactam antibiotics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM 1	amoxicillin/clavulanate potassium 1gm	-

Primary Outcome Measures

Name	Time	Method
Clinical response at 10 - 14 days post therapy	10 - 14 days

Secondary Outcome Measures

Name	Time	Method
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)	2 - 4 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇰 Lahore, Pakistan