Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection
N Engl J Med 2015 Dec 24; V.373 N.26 P.2512-2521
William M. Geisler, M.D., M.P.H., Apurva Uniyal, M.A., Jeannette Y. Lee, Ph.D., Shelly Y. Lensing, M.S., Shacondra Johnson, B.S.P.H., Raymond C.W. Perry, M.D., M.S.H.S., Carmel M. Kadrnka, D.O., and Peter R. Kerndt, M.D., M.P.H.
From the Department of Medicine, University of Alabama at Birmingham, Birmingham (W.M.G.); the Departments of Preventive Medicine (A.U., P.R.K.) and Internal Medicine (P.R.K), University of Southern California, and Los Angeles County Department of Health Services, Juvenile Court Health Services R.C.W.P., C.M.K.) — both in Los Angeles; the Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); and FHI 360, Durham, NC (S.J.). Address reprint requests to Dr. Geisler at the University of Alabama at Birmingham, 703 19th St. S., 242 Zeigler Research Bldg., Birmingham, AL 35294-0007, or at email@example.com.
Urogenital Chlamydia trachomatis infection remains prevalent and causes substantial reproductive morbidity. Recent studies have raised concern about the efficacy of azithromycin for the treatment of chlamydia infection.
We conducted a randomized trial comparing oral azithromycin with doxycycline for the treatment of urogenital chlamydia infection among adolescents in youth correctional facilities, to evaluate the noninferiority of azithromycin (1 g in one dose) to doxycycline (100 mg twice daily for 7 days). The treatment was directly observed. The primary end point was treatment failure at 28 days after treatment initiation, with treatment failure determined on the basis of nucleic acid amplification testing, sexual history, and outer membrane protein A (OmpA) genotyping of C. trachomatis strains.
Among the 567 participants enrolled, 284 were randomly assigned to receive azithromycin, and 283 were randomly assigned to receive doxycycline. A total of 155 participants in each treatment group (65% male) made up the per-protocol population. There were no treatment failures in the doxycycline group. In the azithromycin group, treatment failure occurred in 5 participants (3.2%; 95% confidence interval, 0.4 to 7.4%). The observed difference in failure rates between the treatment groups was 3.2 percentage points, with an upper boundary of the 90% confidence interval of 5.9 percentage points, which exceeded the prespecified absolute 5-percentage-point cutoff for establishing the noninferiority of azithromycin.
In the context of a closed population receiving directly observed treatment for urogenital chlamydia infection, the efficacy of azithromycin was 97%, and the efficacy of doxycycline was 100%. The noninferiority of azithromycin was not established in this setting. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00980148.)
Treatment for Chlamydia Infection — Doxycycline versus Azithromycin
Thomas C. Quinn, M.D., and Charlotte A. Gaydos, Dr.P.H.
From the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda (T.C.Q.), and the Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore (T.C.Q., C.A.G.) — both in Maryland.
Chlamydia trachomatis infection is the most common bacterial sexually transmitted infection in the United States. In 2013, a total of 1.4 million cases were reported, and 3 million persons were estimated to be infected. Worldwide, 131 million persons are estimated to be infected with C. trachomatis. Untreated infections in women can result in pelvic inflammatory disease, infertility, ectopic pregnancy, and chronic pelvic pain. In men, the infection can be associated with urethritis, epididymitis, and, in men who have sex with men, proctitis. The Centers for Disease Control and Prevention (CDC) recommends that all sexually active women younger than 25 years of age undergo annual chlamydia screening.1 However, less than half of women 16 to 24 years of age who are enrolled in medical care programs were screened in 2013…..