Last updated: 11/03/2018 00:26:24
AUGMENTIN 1gm In Skin And Soft Tissue Infection
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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