Safety and efficacy of WC2031 versus vibramycin for the treatment of
uncomplicated urogenital Chlamydia trachomatis infection: a randomized,
double-blind, double-dummy, active-controlled, multicenter trial.
Author(s): Geisler WM, Koltun WD, Abdelsayed N, Burigo J, Mena L, Taylor SN, Batteiger BE,
Thurman AR, Hook EW 3rd, Vaughn TA, Annett MP, Muenzen RA, Caminis J.
Affiliation(s): Department of Medicine, University of Alabama at Birmingham, 35294-0007, USA.
wgeisler@uab.edu
Publication date & source: 2012, Clin Infect Dis. , 55(1):82-8
BACKGROUND: Recent studies have raised concern about efficacy of azithromycin for
Chlamydia trachomatis infection. Research investigating new antibiotic regimens
for chlamydia has been sparse, especially regimens that may reduce adherence
difficulties with the recommended twice-daily doxycycline regimen.
METHODS: We conducted a randomized, double-blind, double-dummy,
active-controlled, multicenter trial with the objective of evaluating the safety
and efficacy of WC2031 (doxycycline hyclate delayed-release 200-mg tablet) orally
once daily for 7 days versus Vibramycin (doxycycline hyclate capsule) 100 mg
orally twice daily for 7 days for treatment of uncomplicated urogenital
chlamydia. Men and nonpregnant women aged 19-45 years with a urogenital
chlamydial diagnosis or a sexual partner with chlamydia were eligible. The
primary outcome was microbial cure by nucleic acid amplification testing at day
28. Noninferiority of WC2031 was inferred if the lower limit of the 95%
confidence interval (CI) of the difference in cure rates was >-10%.
RESULTS: A total of 495 subjects were randomized. The modified intent-to-treat
(mITT) population with evaluable efficacy consisted of 323 subjects. Baseline
patient characteristics did not differ between the mITT groups. Microbial cure
rates for WC2031 were 95.5% (95% CI, 92.3-98.8) versus 95.2% (95% CI, 92.0-98.4)
for Vibramycin (95% CI for the difference in cure rates, -4.3% to 4.9%). Types of
adverse events were comparable. Nausea and vomiting occurred less frequently with
WC2031 than with Vibramycin (13% vs 21% and 8% vs 12%, respectively).
CONCLUSIONS: WC2031 was noninferior to Vibramycin for uncomplicated urogenital
chlamydia treatment, better tolerated, and demonstrated comparable safety. WC2031
could improve treatment adherence over twice-daily Vibramycin.
CLINICAL TRIALS REGISTRATION: NCT01113931.
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