AUGMENTIN 1gm In Skin And Soft Tissue Infection - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00343135

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 IV

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:

MedlinePlus related topics: Potassium Skin Conditions Skin Infections

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Clavulanate potassium Amoxicillin trihydrate Amoxicillin-potassium clavulanate combination Potassium chloride

U.S. FDA Resources

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, 54000
GSK Investigational Site
Lahore, Pakistan

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00343135 History of Changes
Other Study ID Numbers:	103997
Study First Received:	June 20, 2006
Last Updated:	June 16, 2011
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 February 09, 2012