Pharmacokinetics of azithromycin 1 gram single dose in anorectal tissue and serum
Pharmacokinetics of azithromycin 1 gram single dose in anorectal tissue and serum in healthy men
University of Melbourne
10 participants
Jan 1, 2016
Interventional
Conditions
Summary
There are increasing concerns regarding the treatment efficacy of azithromycin 1g single dose for the treatment of rectal chlamydia infections with treatment failure rates up to 21% being reported. There is no pharmacokinetic data available to determine if low rectal tissue concentrations contribute to treatment failure. The purpose of this study is to provide the world first evidence of the pharmacokinetics of azithromycin 1g in rectal tissue
Eligibility
Inclusion Criteria3
- Men who are HIV/STI free and chlamydia negative
- Men aged 18 years and over
- Adequate English and comprehension skills to give informed consent
Exclusion Criteria6
- Self-report of antibiotic use in the last 2 weeks
- Current commercial sex work
- Men who do not have a mobile phone
- HIV positive status
- Concurrent medication likely to significantly interact with azithromycin (e.g. cyclosporine, digoxin)
- Known macrolide allergy or contraindications
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Interventions
Azithromycin 1g single dose (oral tablet), with food by direct observation.
Locations(1)
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ACTRN12616001666415