 |
|
Azithromycin for Empirical Treatment of the Nongonococcal Urethritis Syndrome in MenA Randomized Double-blind Study
Walter E. Stamm, MD;
Charles B. Hicks, MD;
David H. Martin, MD;
Peter Leone, MD;
Edward W. Hook III, MD;
Ronald H. Cooper, MD;
Myron S. Cohen, MD;
Byron E. Batteiger, MD;
Kimberly Workowski, MD;
William M. McCormack, MD;
Gail Bolan, MD;
John M. Douglas, Jr, MD;
Edward S. Wong, MD;
Peter G. Pappas, MD;
Raymond B. Johnson, MD
JAMA. 1995;274(7):545-549.
Abstract
| |
Objective.
—To evaluate the use of single-dose azithromycin for empirical treatment of nongonococcal urethritis.
Design.
—Randomized, double-blind, multicenter trial comparing azithromycin vs doxycycline therapy, with a 2:1 randomization ratio. Patients were evaluated clinically and microbiologically for Chlamydia trachomatis and Ureaplasma urealyticum infection before therapy and at 2 and 5 weeks after study entry.
Setting.
—Eleven sexually transmitted disease clinics throughout the United States.
Patients.
—A total of 452 men aged 18 years or older with symptomatic nongonococcal urethritis of less than 14 days' duration.
Intervention.
—Patients were treated with either 1.0 g of azithromycin as a single oral dose or 100 mg of doxycycline taken orally twice daily for 7 days.
Main Outcome Measures.
—Clinical resolution of symptoms and signs of nongonococcal urethritis, microbiological cure of C trachomatis and U urealyticum, and occurrence of adverse experiences.
Results.
—Of the 452 patients enrolled, 248 in the azithromycin-treated group and 123 in the doxycycline-treated group were evaluable for clinical response. The two treatment groups were comparable in terms of age, weight, ethnic distribution, sexual preference, sexual activity, and history of prior nongonococcal urethritis or gonorrhea. Sixteen percent of the azithromycin group and 24% of the doxycycline group were culture positive for C trachomatis before therapy, while 38% and 28%, respectively, were culture positive for U urealyticum. The cumulative clinical cure rate was 81% (95% confidence interval [CI], 75% to 85%) in the azithromycin-treated group and 77% (95% CI, 69% to 84%) in the doxycycline-treated group. Clinical cure rates in the two groups were also comparable when patients were stratified by presence or absence of infection with C trachomatis or U urealyticum prior to therapy. Among those infected with C trachomatis, overall microbiological cure rates were 83% (95% CI, 65% to 94%) for azithromycin-treated patients (n=30) and 90% (95% CI, 68% to 98%) for doxycycline-treated patients (n=21). Among those infected with U urealyticum, overall microbiological cure rates were 45% (95% CI, 34% to 57%) for azithromycin-treated patients (n=75) and 47% (95% CI, 30% to 65%) for doxycycline-treated patients (n=32). Adverse reactions were generally mild to moderate and occurred in 23% of the azithromycin-treated group and 29% of the doxycycline-treated group.
Conclusions.
—For empirical treatment of the acute nongonococcal urethritis syndrome in men, a single oral dose of azithromycin was as effective as a standard 7-day course of doxycycline in achieving clinical cure. Further, clinical cure rates were comparable with either regimen, regardless of the presence or absence of Chlamydia or Ureaplasma infection.
(JAMA. 1995;274:545-549)
Author Affiliations
From the University of Washington, Seattle (Drs Stamm and Workowski); Duke University Medical Center, Durham, NC (Dr Hicks); Louisiana State University School of Medicine, New Orleans (Dr Martin); University of North Carolina, Chapel Hill (Drs Leone and Cohen); University of Alabama, Birmingham (Drs Hook and Pappas); Madigan Army Medical Center, Tacoma, Wash (Dr Cooper); Indiana University School of Medicine, Indianapolis (Dr Batteiger); The State University of New York, Brooklyn (Dr McCormack); STD Control Program, San Francisco, Calif (Dr Bolan); Denver (Colo) Department of Public Health (Dr Douglas); Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Va (Dr Wong); and Pfizer Central Research, Groton, Conn (Dr Johnson).
Footnotes
Dr Johnson is a senior associate director of Pfizer Central Research, the manufacturer of azithromycin.
Reprint requests to Harborview Medical Center, ZA89, 325 Ninth Ave, Seattle, WA 98104 (Dr Stamm).
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati  Twitter
What's this?
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Incidence and antimicrobial susceptibilities of genital mycoplasmas in outpatient women with clinical vaginitis in Athens, Greece
Kechagia et al.
J Antimicrob Chemother 2008;62:122-125.
ABSTRACT
| FULL TEXT
Efficacy of Azithromycin versus Systemic Meglumine Antimoniate (Glucantime) in the Treatment of Cutaneous Leishmaniasis
Layegh et al.
Am J Trop Med Hyg 2007;77:99-101.
ABSTRACT
| FULL TEXT
High Prevalence of Genital Mycoplasmas among Sexually Active Young Adults with Urethritis or Cervicitis Symptoms in La Crosse, Wisconsin
Schlicht et al.
J. Clin. Microbiol. 2004;42:4636-4640.
ABSTRACT
| FULL TEXT
Tetracycline treatment does not eradicate Mycoplasma genitalium
Falk et al.
Sex. Transm. Infect. 2003;79:318-319.
ABSTRACT
| FULL TEXT
Correlation between culture testing of swabs and ligase chain reaction of first void urine from patients recently treated for Chlamydia trachomatis
Jang et al.
Sex. Transm. Infect. 2003;79:237-239.
ABSTRACT
| FULL TEXT
Chlamydia trachomatis Testing
Reust
Arch Fam Med 2000;9:885-886.
FULL TEXT
Azithromycin Compared with Penicillin G Benzathine for Treatment of Incubating Syphilis
Hook et al.
ANN INTERN MED 1999;131:434-437.
ABSTRACT
| FULL TEXT
Single-Dose Therapy for Nongonococcal Urethritis
Journal Watch Dermatology 1995;1995:14-14.
FULL TEXT
SINGLE DOSE THERAPY OF NONGONOCOCCAL URETHRITIS IN MEN
JWatch General 1995;1995:2-2.
FULL TEXT
Evolving Strategies for Management of the Nongonococcal Urethritis Syndrome
Schmid and Fontanarosa
JAMA 1995;274:577-579.
ABSTRACT
|
