Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men: A randomized double-blind study

Walter E. Stamm, Charles B. Hicks, David H. Martin, Peter Leone, Edward W. Hook, Ronald H. Cooper, Myron S. Cohen, Byron E. Batteiger, Kimberly Workowski, Byron Batteiger, Gail Bolan, John M. Douglas, Edward S. Wong, Peter G. Pappas, Raymond B. Johnson

Research output: Contribution to journalArticle

131 Citations (Scopus)

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 [Cl], 75% to 85%) in the azithromycin-treated group and 77% (95% Cl, 69% to 84%) in the doxycycline-treated group. Clinical cure rates in the two groups were also comparable when patients were stratified by pres-ence 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% Cl, 65% to 94%) for azithromycin-treated patients (n=30) and 90% (95% Cl, 68% to 98%) for doxycycline-treated patients (n=21). Among those infected with U urealyticum, overall microbiological cure rates were 45% (95% Cl, 34% to 57%) for azithromycin-treated patients (n=75) and 47% (95% Cl, 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.

Original languageEnglish
Pages (from-to)545-549
Number of pages5
JournalJournal of the American Medical Association
Volume274
Issue number7
StatePublished - Aug 16 1995

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Urethritis
Azithromycin
Doxycycline
Double-Blind Method
Ureaplasma Infections
Therapeutics
Ureaplasma urealyticum
Chlamydia Infections
Gonorrhea
Chlamydia trachomatis
Random Allocation
Sexually Transmitted Diseases
Sexual Behavior
Multicenter Studies
Signs and Symptoms
Outcome Assessment (Health Care)
Confidence Intervals
Weights and Measures

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Stamm, W. E., Hicks, C. B., Martin, D. H., Leone, P., Hook, E. W., Cooper, R. H., ... Johnson, R. B. (1995). Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men: A randomized double-blind study. Journal of the American Medical Association, 274(7), 545-549.

Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men : A randomized double-blind study. / Stamm, Walter E.; Hicks, Charles B.; Martin, David H.; Leone, Peter; Hook, Edward W.; Cooper, Ronald H.; Cohen, Myron S.; Batteiger, Byron E.; Workowski, Kimberly; Batteiger, Byron; Bolan, Gail; Douglas, John M.; Wong, Edward S.; Pappas, Peter G.; Johnson, Raymond B.

In: Journal of the American Medical Association, Vol. 274, No. 7, 16.08.1995, p. 545-549.

Research output: Contribution to journalArticle

Stamm, WE, Hicks, CB, Martin, DH, Leone, P, Hook, EW, Cooper, RH, Cohen, MS, Batteiger, BE, Workowski, K, Batteiger, B, Bolan, G, Douglas, JM, Wong, ES, Pappas, PG & Johnson, RB 1995, 'Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men: A randomized double-blind study', Journal of the American Medical Association, vol. 274, no. 7, pp. 545-549.
Stamm, Walter E. ; Hicks, Charles B. ; Martin, David H. ; Leone, Peter ; Hook, Edward W. ; Cooper, Ronald H. ; Cohen, Myron S. ; Batteiger, Byron E. ; Workowski, Kimberly ; Batteiger, Byron ; Bolan, Gail ; Douglas, John M. ; Wong, Edward S. ; Pappas, Peter G. ; Johnson, Raymond B. / Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men : A randomized double-blind study. In: Journal of the American Medical Association. 1995 ; Vol. 274, No. 7. pp. 545-549.
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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 [Cl], 75{\%} to 85{\%}) in the azithromycin-treated group and 77{\%} (95{\%} Cl, 69{\%} to 84{\%}) in the doxycycline-treated group. Clinical cure rates in the two groups were also comparable when patients were stratified by pres-ence 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{\%} Cl, 65{\%} to 94{\%}) for azithromycin-treated patients (n=30) and 90{\%} (95{\%} Cl, 68{\%} to 98{\%}) for doxycycline-treated patients (n=21). Among those infected with U urealyticum, overall microbiological cure rates were 45{\%} (95{\%} Cl, 34{\%} to 57{\%}) for azithromycin-treated patients (n=75) and 47{\%} (95{\%} Cl, 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.",
author = "Stamm, {Walter E.} and Hicks, {Charles B.} and Martin, {David H.} and Peter Leone and Hook, {Edward W.} and Cooper, {Ronald H.} and Cohen, {Myron S.} and Batteiger, {Byron E.} and Kimberly Workowski and Byron Batteiger and Gail Bolan and Douglas, {John M.} and Wong, {Edward S.} and Pappas, {Peter G.} and Johnson, {Raymond B.}",
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day = "16",
language = "English",
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TY - JOUR

T1 - Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men

T2 - A randomized double-blind study

AU - Stamm, Walter E.

AU - Hicks, Charles B.

AU - Martin, David H.

AU - Leone, Peter

AU - Hook, Edward W.

AU - Cooper, Ronald H.

AU - Cohen, Myron S.

AU - Batteiger, Byron E.

AU - Workowski, Kimberly

AU - Batteiger, Byron

AU - Bolan, Gail

AU - Douglas, John M.

AU - Wong, Edward S.

AU - Pappas, Peter G.

AU - Johnson, Raymond B.

PY - 1995/8/16

Y1 - 1995/8/16

N2 - 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 [Cl], 75% to 85%) in the azithromycin-treated group and 77% (95% Cl, 69% to 84%) in the doxycycline-treated group. Clinical cure rates in the two groups were also comparable when patients were stratified by pres-ence 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% Cl, 65% to 94%) for azithromycin-treated patients (n=30) and 90% (95% Cl, 68% to 98%) for doxycycline-treated patients (n=21). Among those infected with U urealyticum, overall microbiological cure rates were 45% (95% Cl, 34% to 57%) for azithromycin-treated patients (n=75) and 47% (95% Cl, 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.

AB - 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 [Cl], 75% to 85%) in the azithromycin-treated group and 77% (95% Cl, 69% to 84%) in the doxycycline-treated group. Clinical cure rates in the two groups were also comparable when patients were stratified by pres-ence 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% Cl, 65% to 94%) for azithromycin-treated patients (n=30) and 90% (95% Cl, 68% to 98%) for doxycycline-treated patients (n=21). Among those infected with U urealyticum, overall microbiological cure rates were 45% (95% Cl, 34% to 57%) for azithromycin-treated patients (n=75) and 47% (95% Cl, 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.

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