NCT00343135

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

June 20, 2006

Last Update Submit

November 21, 2012

Conditions

Skin Diseases, InfectiousInfection, Soft Tissue

Keywords

SkinAUGMENTIN1gmSofttissueInfections

Outcome Measures

Primary Outcomes (1)

  • Clinical response at 10 - 14 days post therapy

    10 - 14 days

Secondary Outcomes (1)

  • 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

Study Arms (1)

ARM 1

EXPERIMENTAL
Drug: amoxicillin/clavulanate potassium 1gm

Interventions

amoxicillin/clavulanate potassium 1gmDRUG

amoxicillin/clavulanate potassium 1gm

ARM 1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Karachi, Pakistan

Location

GSK Investigational Site

Lahore, 54000, Pakistan

Location

GSK Investigational Site

Lahore, Pakistan

Location

MeSH Terms

Conditions

Skin Diseases, InfectiousSoft Tissue InfectionsInfections

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 22, 2006

Study Start

December 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

PA(3)