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

Abstract

BackgroundRectal 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/DesignThe 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.DiscussionRectal 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001125617.

The efficacy of azithromycin and doxycycline treatment for rectal chlamydial infection: a retrospective cohort study in South Australia

“…5,6 With the widespread adoption of MET/RRT there has been a consistent signal for reduction in the rates of cardiac arrests and unexpected deaths with a variety of team compositions. [7][8][9][10][11][12][13][14][15][16][17] RRT implementation has also been associated with reduction in hospital mortality…”

“…Current sexually transmitted infections (STI) treatment guidelines recommend azithromycin (1 g single dose) or doxycycline (100 mg twice a day for 7 days) for the treatment of rectal chlamydial infection . To date, there is only one double‐blinded randomised controlled trial planned comparing antibiotic therapy for rectal chlamydial infection …”

“…[12][13][14][15] To date, there is only one double-blinded randomised controlled trial planned comparing antibiotic therapy for rectal chlamydial infection. 16 In this study, we aim to review the efficacy of 1 g of azithromycin as a single dose compared with 100 mg of doxycycline twice daily for 10 days following our clinic guidelines in the treatment of rectal chlamydial infection in men and women attending the sexual health clinic in Adelaide, Australia.…”

Chlamydiae from Down Under: The Curious Cases of Chlamydial Infections in Australia

“…Outbreaks of lymphogranuloma venereum (LGV) leading to ulcerative proctitis have persisted in Australia for over a decade among MSM populations [27][28][29][30]. Whilst most of these infections are of an anorectal nature, recent cases of LGV had a clinical presentation of penile ulcers [30].…”

Azithromycin Efficacy in Asymptomatic Rectal Chlamydial Infection in Men Who Have Sex With Men: A More Definitive Answer Soon?

“…The good news is that such an RCT of azithromycin versus doxycycline for the treatment of asymptomatic rectal infection in MSM is underway in Australia. The study protocol has been recently published (11). The Rectal Treatment Study aims to recruit 700 MSM with rectal detection of CT by NAAT, without symptoms of proctitis.…”