Treatment efficacy of azithromycin 1 g single dose versus doxycycline 100 mg twice daily for 7 days for the treatment of rectal chlamydia among men who have sex with men – a double-blind randomised controlled trial protocol

Andrew Lau; Fabian Kong; Christopher K Fairley; Basil Donovan; Marcus Chen; Catriona Bradshaw; Mark Boyd; Janaki Amin; Peter Timms; Sepehr Tabrizi; David G Regan; David A Lewis; Anna McNulty; Jane S Hocking

doi:10.1186/s12879-016-2125-7

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Treatment efficacy of azithromycin 1 g single dose versus doxycycline 100 mg twice daily for 7 days for the treatment of rectal chlamydia among men who have sex with men – a double-blind randomised controlled trial protocol

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Treatment efficacy of azithromycin 1 g single dose versus doxycycline 100 mg twice daily for 7 days for the treatment of rectal chlamydia among men who have sex with men – a double-blind randomised controlled trial protocol

Andrew Lau, Fabian Kong, Christopher K Fairley, Basil Donovan, Marcus Chen, Catriona Bradshaw, Mark Boyd, Janaki Amin, Peter Timms, Sepehr Tabrizi, …

BMC Infectious Diseases, Vol.17, 35

2017

DOI: https://doi.org/10.1186/s12879-016-2125-7

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Abstract

chlamydia

rectal

treatment

MSM

azithromycin

doxycycline

Background: Rectal infection with Chlamydia trachomatis is one of the most common bacterial sexually transmissible infections among men who have sex with men (MSM) with diagnosis rates continuing to rise. Current treatment guidelines recommend either azithromycin 1 g single dose or doxycycline 100 mg twice daily for 7 days. However, there are increasing concerns about treatment failure with azithromycin. We are conducting the first randomised controlled trial (RCT) to compare treatment efficacy of azithromycin versus doxycycline for the treatment of rectal chlamydia in MSM. Methods/Design: The Rectal Treatment Study will recruit 700 MSM attending Australian sexual health clinics for the treatment of rectal chlamydia. Participants will be asked to provide rectal swabs and will be randomised to either azithromycin 1 g single dose or doxycycline 100 mg twice daily for 7 days. Participants will be asked to complete questionnaires about adverse drug reactions, sexual behaviour and drug adherence via short message service and online survey. The primary outcome is the treatment efficacy as determined by a negative chlamydia nucleic acid amplification test at 4 weeks post treatment. Secondary outcomes will utilise whole genome sequencing and mRNA assay to differentiate between treatment failure, reinfection or false positive results. Discussion: Rectal chlamydia is an increasing public health concern as use of pre-exposure prophylaxis against HIV becomes commonplace. Optimal, evidence-based treatment is critical to halting ongoing transmission. This study will provide the first RCT evidence comparing azithromycin and doxycycline for the treatment of rectal chlamydia. The results of this trial will establish which treatment is more efficacious and inform international management guidelines.

Details

Title: Treatment efficacy of azithromycin 1 g single dose versus doxycycline 100 mg twice daily for 7 days for the treatment of rectal chlamydia among men who have sex with men – a double-blind randomised controlled trial protocol
Authors: Andrew Lau (Author) - University of Melbourne
Fabian Kong (Author) - University of Melbourne
Christopher K Fairley (Author) - Melbourne Sexual Health Centre
Basil Donovan (Author) - UNSW
Marcus Chen (Author) - Melbourne Sexual Health Centre
Catriona Bradshaw (Author) - University of Melbourne
Mark Boyd (Author) - UNSW
Janaki Amin (Author) - UNSW
Peter Timms (Author) - University of the Sunshine Coast - Faculty of Science, Health, Education and Engineering
Sepehr Tabrizi (Author) - University of Melbourne
David G Regan (Author) - UNSW
David A Lewis (Author) - Western Sydney Sexual Health Centre
Anna McNulty (Author) - Sydney Sexual Health Centre
Jane S Hocking (Author) - University of Melbourne
Publication details: BMC Infectious Diseases, Vol.17, 35; 9
Publisher: BioMed Central Ltd.
Date published: 2017
DOI: 10.1186/s12879-016-2125-7
ISSN: 1471-2334
Copyright note: Copyright © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
Organisation Unit: University of the Sunshine Coast, Queensland; Centre for Bioinnovation
Language: English
Record Identifier: 99451177002621
Output Type: Journal article

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