TY - JOUR
T1 - Treatment Effectiveness of Azithromycin and Doxycycline in Uncomplicated Rectal and Vaginal Chlamydia trachomatis Infections in Women
T2 - A Multicenter Observational Study (FemCure)
AU - Dukers-Muijrers, Nicole H. T. M.
AU - Wolffs, Petra F. G.
AU - de Vries, Henry
AU - Gotz, Hannelore M.
AU - Heijman, Titia
AU - Bruisten, Sylvia
AU - Eppings, Lisanne
AU - Hogewoning, Arjan
AU - Steenbakkers, Mieke
AU - Lucchesi, Mayk
AU - van der Loeff, Maarten F. Schim
AU - Hoebe, Christian J. P. A.
N1 - Funding Information:
All participants provided written informed consent. This study was approved by the Medical Ethical Review Committee from the Maastricht University Medical Centre, the Netherlands (NL51358.068.15/METC153020, 20-01-2016). This study was monitored by the Clinical Trial Centre Maastricht (Maastricht University).
Funding Information:
This work was funded by a governmental organization grant from the Netherlands Organization for Health Research and Development (ZonMW Netherlands); ProjectID: 50-53000-98-109. The authors thank the staff at the Public Health Service (GGD) South Limburg (Ronald van Hoorn, Maria Mergelsberg, Mandy Sanders, Emily Suijlen, Bianca Penders, Helen Sijstermans, Ine de Bock, Julien Weijers, Patricia Zaandam, Jeanine Leenen, Jeanne Heil, Stephanie Brinkhues, and Genevieve van Liere); the staff at GGD Rotterdam-Rijnmond (Astrid Wielemaker, Angie Martina, Roselyne Uwimana, Mieke Illidge, and Klaas de Ridder); and the staff at GGD Amsterdam (Dieke Martini, Myra van Leeuwen, Claudia Owusu, Jacqueline Woutersen, Princella Felipa, Mayam Amezian, Arjdal Khadija, and Iris Deen), who were involved in the logistics, recruitment, and enrollment of the study. They also thank Martijn van Rooijen for data management, and Anders Boyd for statistical advice. They thank the staff at the laboratories of medical microbiology of the Maastricht University Medical Center, especially Judith Veugen, Laura Saelmans, and Kevin Janssen. Additionally, they thank the staff of the microbiological laboratory of the GGD Amsterdam, especially Esther Heuser and Michelle Himschoot. Finally, they thank the members of the advisory committee of this study for providing excellent input on the design of the study and feedback on this paper, from the National Institute for Public Health and the environment (Jan van Bergen, Birgit van Benthem) and from the University of Maastricht (Gerjo Kok and Servaas Morre).
Funding Information:
Financial support. This work was funded by a governmental organization grant from the Netherlands Organization for Health Research and Development (ZonMW Netherlands); ProjectID: 50-53000-98-109. Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Publisher Copyright:
© 2019 The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - Background. Rectal infections with Chlamydia trachomatis (CT) are prevalent in women visiting a sexually transmitted infection outpatient clinic, but it remains unclear what the most effective treatment is. We assessed the effectiveness of doxycycline and azithromycin for the treatment of rectal and vaginal chlamydia in women.Methods. This study is part of a prospective multicenter cohort study (FemCure). Treatment consisted of doxycycline (100 mg twice daily for 7 days) in rectal CT-positive women, and of azithromycin (1 g single dose) in vaginally positive women who were rectally untested or rectally negative. Participants self-collected rectal and vaginal samples at enrollment (treatment time-point) and during 4 weeks of follow-up. The endpoint was microbiological cure by a negative nucleic acid amplification test at 4 weeks. Differences between cure proportions and 95% confidence intervals (CIs) were calculated.Results. We analyzed 416 patients, of whom 319 had both rectal and vaginal chlamydia at enrollment, 22 had rectal chlamydia only, and 75 had vaginal chlamydia only. In 341 rectal infections, microbiological cure in azithromycin-treated women was 78.5% (95% CI, 72.6%-83.7%; n = 164/209) and 95.5% (95% CI, 91.0%-98.2%; n = 126/132) in doxycycline-treated women (difference, 17.0% [95% CI, 9.6%-24.7%]; P <.001). In 394 vaginal infections, cure was 93.5% (95% CI, 90.1%-96.1%; n = 246/263) in azithromycin-treated women and 95.4% (95% CI, 90.9%-98.2%; n = 125/131) in doxycycline-treated women (difference, 1.9% [95% CI, -3.6% to 6.7%]; P = .504).Conclusions. The effectiveness of doxycycline is high and exceeds that of azithromycin for the treatment of rectal CT infections in women.
AB - Background. Rectal infections with Chlamydia trachomatis (CT) are prevalent in women visiting a sexually transmitted infection outpatient clinic, but it remains unclear what the most effective treatment is. We assessed the effectiveness of doxycycline and azithromycin for the treatment of rectal and vaginal chlamydia in women.Methods. This study is part of a prospective multicenter cohort study (FemCure). Treatment consisted of doxycycline (100 mg twice daily for 7 days) in rectal CT-positive women, and of azithromycin (1 g single dose) in vaginally positive women who were rectally untested or rectally negative. Participants self-collected rectal and vaginal samples at enrollment (treatment time-point) and during 4 weeks of follow-up. The endpoint was microbiological cure by a negative nucleic acid amplification test at 4 weeks. Differences between cure proportions and 95% confidence intervals (CIs) were calculated.Results. We analyzed 416 patients, of whom 319 had both rectal and vaginal chlamydia at enrollment, 22 had rectal chlamydia only, and 75 had vaginal chlamydia only. In 341 rectal infections, microbiological cure in azithromycin-treated women was 78.5% (95% CI, 72.6%-83.7%; n = 164/209) and 95.5% (95% CI, 91.0%-98.2%; n = 126/132) in doxycycline-treated women (difference, 17.0% [95% CI, 9.6%-24.7%]; P <.001). In 394 vaginal infections, cure was 93.5% (95% CI, 90.1%-96.1%; n = 246/263) in azithromycin-treated women and 95.4% (95% CI, 90.9%-98.2%; n = 125/131) in doxycycline-treated women (difference, 1.9% [95% CI, -3.6% to 6.7%]; P = .504).Conclusions. The effectiveness of doxycycline is high and exceeds that of azithromycin for the treatment of rectal CT infections in women.
KW - women
KW - Chlamydia trachomatis
KW - rectal
KW - treatment effectiveness
KW - NEISSERIA-GONORRHOEAE
KW - RETROSPECTIVE COHORT
KW - MEN
KW - EFFICACY
KW - THERAPY
U2 - 10.1093/cid/ciz050
DO - 10.1093/cid/ciz050
M3 - Article
C2 - 30689759
SN - 1058-4838
VL - 69
SP - 1946
EP - 1954
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 11
ER -