AUGMENTIN 1gm In Skin And Soft Tissue Infection | NCT00343135

Studies
AUGMENTIN 1gm In Skin And Soft Tissue Infection

NCT00343135

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 22, 2012Estimated

Enrollment

195Actual

Phase

Phase 4

Conditions

Skin Diseases, Infectious
Infection, Soft Tissue

Interventions

amoxicillin/clavulanate potassium 1gm

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Jun 20, 2006

First Submission Date that Met QC Criteria

Jun 20, 2006

First Posted Date

Jun 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2012

Last Update Posted Date

Nov 22, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

195Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARM 1	Experimental		Drug: amoxicillin/clavulanate potassium 1gm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amoxicillin/clavulanate potassium 1gm	Drug	amoxicillin/clavulanate potassium 1gm	ARM 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical response at 10 - 14 days post therapy		10 - 14 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Karachi			Pakistan
GSK Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D012874	Skin Diseases, Infectious
D018461	Soft Tissue Infections
D007239	Infections

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided