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AUGMENTIN 1gm In Skin And Soft Tissue Infection

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00343135
Enrollment
195
Registered
2006-06-22
Start date
2004-12-31
Completion date
2005-03-31
Last updated
2012-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Soft Tissue, Skin Diseases, Infectious

Keywords

Skin, AUGMENTIN, 1gm, Soft, tissue, Infections

Brief summary

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

Interventions

DRUGamoxicillin/clavulanate potassium 1gm

amoxicillin/clavulanate potassium 1gm

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical response at 10 - 14 days post therapy10 - 14 days

Secondary

MeasureTime 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026