None listed
Conditions
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 evidence available from randomised controlled trials directly comparing doxycycline with azithromycin for the treatment of rectal chlamydia with a recent meta-analysis reporting an efficacy of approximately 85% for azithromycin compared with 99% for doxycycline - however, these efficacy estimates are based on poor quality evidence. The purpose of this study is to provide the world first evidence on the treatment efficacy of the two recommended treatments for rectal chlamydia - azithromycin 1g single dose versus 7 days of doxycycline (100mg twice a day)
Interventions
Oral azithromycin 1g single dose plus oral placebo doxycycline twice a day for 7 days (with the first dose of placebo doxycycline taken at the same time as the azithromycin dose)
OR
Oral doxycycline 100mg twice a day for 7 day plus oral placebo azithromycin single dose (with the placebo dose of azithromycin taken at the same time as the first doxycycline dose)
Compliance will be measured by answering a text message at end of week 1 about drug adherence. They will be also asked to return the p
Oral azithromycin 1g single dose plus oral placebo doxycycline twice a day for 7 days (with the first dose of placebo doxycycline taken at the same time as the azithromycin dose) OR Oral doxycycline 100mg twice a day for 7 day plus oral placebo azithromycin single dose (with the placebo dose of azithromycin taken at the same time as the first doxycycline dose) Compliance will be measured by answering a text message at end of week 1 about drug adherence. They will be also asked to return the pill bottle for pill count as a proxy measure of drug compliance at the conclusion of the trial.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consecutive English-speaking men aged 16 years or older, with rectal chlamydia meeting the eligibility criteria will be recruited and followed up for 4 weeks. Inclusion criteria * Men who report male to male sexual contact and are aged 16 years or older who test positive for rectal chlamydia using a Nucleic Acid Amplification Test (NAAT). * Adequate English and comprehension skills to give informed consent
Exclusion criteria
Men will be excluded: i. they present with proctitis/other symptoms. ii. are concurrently diagnosed with another bacterial STI iii. Self-reported use of antibiotics in the last 2 weeks iv. Known contraindications to the use of azithromycin or doxycycline including allergy
Outcome results
None listed