Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/103673
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Type: Journal article
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
Author: Lau, A.
Kong, F.
Fairley, C.
Donovan, B.
Chen, M.
Bradshaw, C.
Boyd, M.
Amin, J.
Timms, P.
Tabrizi, S.
Regan, D.
Lewis, D.
McNulty, A.
Hocking, J.
Citation: BMC Infectious Diseases, 2017; 17(1):35-1-35-9
Publisher: BioMed Central
Issue Date: 2017
ISSN: 1471-2334
1471-2334
Statement of
Responsibility: 
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 and Jane S. Hocking
Abstract: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614001125617.
Keywords: Chlamydia; MSM; azithromycin; doxycycline; rectal; treatment
Rights: © 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.
RMID: 0030062243
DOI: 10.1186/s12879-016-2125-7
Grant ID: http://purl.org/au-research/grants/nhmrc/1124172
Appears in Collections:Medical Sciences publications

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