Andrew Lau1, Fabian Y S Kong1, Christopher K Fairley1, David J Templeton1, Janaki Amin1, Samuel Phillips1, Matthew Law1, Marcus Y Chen1, Catriona S Bradshaw1, Basil Donovan1, Anna McNulty1, Mark A Boyd1, Peter Timms1, Eric P F Chow1, David G Regan1, Carole Khaw1, David A Lewis1, John Kaldor1, Mahesh Ratnayake1, Natalie Carvalho1, Jane S Hocking1. 1. From the University of Melbourne (A.L., F.Y.S.K., S.P., E.P.F.C., N.C., J.S.H.), the Melbourne Sexual Health Centre (C.K.F., M.Y.C., C.S.B., E.P.F.C., J.S.H.), and Monash University (C.K.F., M.Y.C., C.S.B., E.P.F.C.), Melbourne, VIC, Macquarie University, Macquarie, NSW (J.A.), Central Clinical School, Faculty of Medicine and Health, University of Sydney (D.J.T.), Sydney Sexual Health Centre (A.M., B.D.), and the School of Population Health (A.M.) and the Kirby Institute (D.J.T., M.L., B.D., D.G.R., J.K., J.A.), University of New South Wales, Sydney, the Department of Sexual Health Medicine and Sexual Assault Medicine, Sydney Local Health District, Camperdown, NSW (D.J.T.), Western Sydney Sexual Health Centre, Parramatta, NSW, and Westmead Clinical School, University of Sydney, Westmead, NSW (D.A.L.), the Adelaide Sexual Health Centre (C.K., M.R.) and the University of Adelaide (M.A.B.), Adelaide, SA, and the University of the Sunshine Coast, Sippy Downs, QLD (P.T.) - all in Australia.
Abstract
BACKGROUND: Rectal chlamydia is a common bacterial sexually transmissible infection among men who have sex with men. Data from randomized, controlled trials are needed to guide treatment. METHODS: In this double-blind trial conducted at five sexual health clinics in Australia, we randomly assigned men who have sex with men and who had asymptomatic rectal chlamydia to receivedoxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose). Asymptomatic chlamydia was selected as the trial focus because more than 85% of men with rectal chlamydia infection are asymptomatic, and clinical guidelines recommend a longer treatment course for symptomatic infection. The primary outcome was a negative nucleic acid amplification test for rectal chlamydia (microbiologic cure) at 4 weeks. RESULTS:From August 2016 through August 2019, we enrolled 625 men (314 in the doxycycline group and 311 in the azithromycin group). Primary outcome data were available for 290 men (92.4%) in the doxycycline group and 297 (95.5%) in the azithromycin group. In the modified intention-to-treat population, a microbiologic cure occurred in 281 of 290 men (96.9%; 95% confidence interval [CI], 94.9 to 98.9) in the doxycycline group and in 227 of 297 (76.4%; 95% CI, 73.8 to 79.1) in the azithromycin group, for an adjusted risk difference of 19.9 percentage points (95% CI, 14.6 to 25.3; P<0.001). Adverse events that included nausea, diarrhea, and vomiting were reported in 98 men (33.8%) in the doxycycline group and in 134 (45.1%) in the azithromycin group (risk difference, -11.3 percentage points; 95% CI, -19.5 to -3.2). CONCLUSIONS: A 7-day course of doxycycline was superior to single-dose azithromycin in the treatment of rectal chlamydia infection among men who have sex with men. (Funded by the National Health and Medical Research Council; RTS Australian New Zealand Clinical Trials Registry number, ACTRN12614001125617.).
RCT Entities:
BACKGROUND: Rectal chlamydia is a common bacterial sexually transmissible infection among men who have sex with men. Data from randomized, controlled trials are needed to guide treatment. METHODS: In this double-blind trial conducted at five sexual health clinics in Australia, we randomly assigned men who have sex with men and who had asymptomatic rectal chlamydia to receive doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose). Asymptomatic chlamydia was selected as the trial focus because more than 85% of men with rectal chlamydia infection are asymptomatic, and clinical guidelines recommend a longer treatment course for symptomatic infection. The primary outcome was a negative nucleic acid amplification test for rectal chlamydia (microbiologic cure) at 4 weeks. RESULTS: From August 2016 through August 2019, we enrolled 625 men (314 in the doxycycline group and 311 in the azithromycin group). Primary outcome data were available for 290 men (92.4%) in the doxycycline group and 297 (95.5%) in the azithromycin group. In the modified intention-to-treat population, a microbiologic cure occurred in 281 of 290 men (96.9%; 95% confidence interval [CI], 94.9 to 98.9) in the doxycycline group and in 227 of 297 (76.4%; 95% CI, 73.8 to 79.1) in the azithromycin group, for an adjusted risk difference of 19.9 percentage points (95% CI, 14.6 to 25.3; P<0.001). Adverse events that included nausea, diarrhea, and vomiting were reported in 98 men (33.8%) in the doxycycline group and in 134 (45.1%) in the azithromycin group (risk difference, -11.3 percentage points; 95% CI, -19.5 to -3.2). CONCLUSIONS: A 7-day course of doxycycline was superior to single-dose azithromycin in the treatment of rectal chlamydia infection among men who have sex with men. (Funded by the National Health and Medical Research Council; RTS Australian New Zealand Clinical Trials Registry number, ACTRN12614001125617.).
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