Last updated: 11/03/2018 00:26:24

AUGMENTIN 1gm In Skin And Soft Tissue Infection

GSK study ID
103997
See study documents
Clinicaltrials.gov ID
NCT00343135
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Clinical response at 10 - 14 days post therapy

Timeframe: 10 - 14 days

Secondary outcomes:

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)

Timeframe: 2 - 4 days

Interventions:
  • Drug: amoxicillin/clavulanate potassium 1gm
    • Enrollment:
    195
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Skin Diseases, Infectious
    Product
    amoxicillin, amoxicillin/clavulanic acid, clavulanic acid
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to March 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
    • has given freely documented consent.
    • antibiotics
    • have renal or hepatic insufficiency
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lahore, Pakistan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Karachi, Pakistan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lahore, Pakistan, 54000
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-31-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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