title: Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.).
authors.affiliation: 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.).
authors.forename: William M
authors.initials: WM
authors.lastname: Geisler
authors.forename: Apurva
authors.initials: A
authors.lastname: Uniyal
authors.forename: Jeannette Y
authors.initials: JY
authors.lastname: Lee
authors.forename: Shelly Y
authors.initials: SY
authors.lastname: Lensing
authors.forename: Shacondra
authors.initials: S
authors.lastname: Johnson
authors.forename: Raymond C W
authors.initials: RC
authors.lastname: Perry
authors.forename: Carmel M
authors.initials: CM
authors.lastname: Kadrnka
authors.forename: Peter R
authors.initials: PR
authors.lastname: Kerndt
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D002690:Chlamydia Infections / Q000188:drug therapy*; D002692:Chlamydia trachomatis / Q000302:isolation & purification; D016001:Confidence Intervals; D023801:Directly Observed Therapy; D004318:Doxycycline / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D011330:Prisons; D012747:Sexual Partners; D017211:Treatment Failure; D014556:Urine / Q000382:microbiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017963:Azithromycin; D004318:Doxycycline