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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001666415

Acronym

NIL

Enrollment

Registered

2016-12-02

Start date

2016-01-01

Completion date

2016-03-31

Last updated

2020-01-13

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

Conditions

None listed

Brief 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

Interventions

Azithromycin 1g single dose (oral tablet), with food by direct observation.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

- 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 criteria

- 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

Outcome results