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2015 ; 373
(26
): 2512-21
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Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection
#MMPMID26699167
Geisler WM
; Uniyal A
; Lee JY
; Lensing SY
; Johnson S
; Perry RC
; Kadrnka CM
; Kerndt PR
N Engl J Med
2015[Dec]; 373
(26
): 2512-21
PMID26699167
show ga
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.).
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