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

William M. Geisler, William D. Koltun, Nader Abdelsayed, John Burigo, Leandro Mena, Stephanie N. Taylor, Byron Batteiger, Andrea R. Thurman, Edward W. Hook, Toby A. Vaughn, Miriam P. Annett, Ruth A. Muenzen, John Caminis

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)82-88
Number of pages7
JournalClinical Infectious Diseases
Volume55
Issue number1
DOIs
StatePublished - Jul 2012

Fingerprint

Chlamydia Infections
Doxycycline
Chlamydia trachomatis
Multicenter Studies
Safety
Chlamydia
Confidence Intervals
Therapeutics
Azithromycin
Sexual Partners
Nucleic Acids
Nausea
Tablets
Capsules
Vomiting
Clinical Trials
Anti-Bacterial Agents

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

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. / Geisler, William M.; Koltun, William D.; Abdelsayed, Nader; Burigo, John; Mena, Leandro; Taylor, Stephanie N.; Batteiger, Byron; Thurman, Andrea R.; Hook, Edward W.; Vaughn, Toby A.; Annett, Miriam P.; Muenzen, Ruth A.; Caminis, John.

In: Clinical Infectious Diseases, Vol. 55, No. 1, 07.2012, p. 82-88.

Research output: Contribution to journalArticle

Geisler, William M. ; Koltun, William D. ; Abdelsayed, Nader ; Burigo, John ; Mena, Leandro ; Taylor, Stephanie N. ; Batteiger, Byron ; Thurman, Andrea R. ; Hook, Edward W. ; Vaughn, Toby A. ; Annett, Miriam P. ; Muenzen, Ruth A. ; Caminis, John. / 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. In: Clinical Infectious Diseases. 2012 ; Vol. 55, No. 1. pp. 82-88.
@article{c2cd7502577c4dc59fd2770fd912ff94,
title = "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",
abstract = "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.",
author = "Geisler, {William M.} and Koltun, {William D.} and Nader Abdelsayed and John Burigo and Leandro Mena and Taylor, {Stephanie N.} and Byron Batteiger and Thurman, {Andrea R.} and Hook, {Edward W.} and Vaughn, {Toby A.} and Annett, {Miriam P.} and Muenzen, {Ruth A.} and John Caminis",
year = "2012",
month = "7",
doi = "10.1093/cid/cis291",
language = "English",
volume = "55",
pages = "82--88",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "1",

}

TY - JOUR

T1 - Safety and efficacy of WC2031 versus vibramycin for the treatment of uncomplicated urogenital chlamydia trachomatis infection

T2 - A randomized, double-blind, double-dummy, active-controlled, multicenter trial

AU - Geisler, William M.

AU - Koltun, William D.

AU - Abdelsayed, Nader

AU - Burigo, John

AU - Mena, Leandro

AU - Taylor, Stephanie N.

AU - Batteiger, Byron

AU - Thurman, Andrea R.

AU - Hook, Edward W.

AU - Vaughn, Toby A.

AU - Annett, Miriam P.

AU - Muenzen, Ruth A.

AU - Caminis, John

PY - 2012/7

Y1 - 2012/7

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84862219188&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84862219188&partnerID=8YFLogxK

U2 - 10.1093/cid/cis291

DO - 10.1093/cid/cis291

M3 - Article

VL - 55

SP - 82

EP - 88

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 1

ER -