Pharmacokinetics of azithromycin 1 gram single dose in anorectal tissue and serum

Phase 4

Completed

• Conditions: rectal chlamydia; Infection - Sexually transmitted infections

• Registration Number: ACTRN12616001666415
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anorectal tissue sample concentrations (mcg/g) of azithromycin post-dose[Baseline (pre-dose), 2 hours, 24 hours and days 2,3,4,7,10 and 14 post dose<br>];Blood concentration (mcg/mL) post azithromycin dose[2 hours post-dose ]

Secondary Outcome Measures

Name	Time	Method
IL[NIL]