Format

Send to

Choose Destination
See comment in PubMed Commons below
N Engl J Med. 2015 Dec 24;373(26):2512-21. doi: 10.1056/NEJMoa1502599.

Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection.

Author information

1
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.).

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.).

PMID:
26699167
PMCID:
PMC4708266
DOI:
10.1056/NEJMoa1502599
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments

    Supplemental Content

    Full text links

    Icon for Atypon Icon for PubMed Central
    Loading ...
    Support Center