AUGMENTIN 1gm In Skin And Soft Tissue Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343135
First received: June 20, 2006
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Skin Diseases, Infectious
Infection, Soft Tissue
Drug: amoxicillin/clavulanate potassium 1gm
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Clinical response at 10 - 14 days post therapy [ Time Frame: 10 - 14 days ]

Secondary Outcome 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 ]

Enrollment: 195
Study Start Date: December 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM 1 Drug: amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm
Other Name: amoxicillin/clavulanate potassium 1gm

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343135

Locations
Pakistan
GSK Investigational Site
Karachi, Pakistan
GSK Investigational Site
Lahore, Pakistan
GSK Investigational Site
Lahore, Pakistan, 54000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343135     History of Changes
Other Study ID Numbers: 103997
Study First Received: June 20, 2006
Last Updated: November 21, 2012
Health Authority: Pakistan: Ministry of Health

Keywords provided by GlaxoSmithKline:
Skin
AUGMENTIN
1gm
Soft
tissue
Infections

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Soft Tissue Infections
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014