Primary Article

Multicenter Randomized Trial of Ofloxacin Versus Cefoxitin and Doxycycline in Outpatient Treatment of Pelvic Inflammatory Disease

Authors: MARK G. MARTENS, MD, STEPHEN GORDON, MD, DABNEY R. YARBOROUGH, MD, SEBASTIAN FARO, MD, PhD, DAVID BINDER MD, ALAN BERKELEY, MD, The Ambulatory PID Research Group 1 From the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston 2 From the Department of Obstetrics and Gynecology, Northside Hospital, Atlanta, Ga 3 From the Department of Surgery, Medical University of South Carolina, Charleston 4 From the Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Tex 5 From the Department of Obstetrics and Gynecology, Temple University, Philadelphia, Pa 6 From the Department of Obstetrics and Gynecology, The New York Hospital-Cornell Medical Center, New York *Ambulatory PID Research Group includes (in addition to the authors): William Ledger, MD, Department of Obstetrics and Gynecology, Cornell University, New York, NY; Subir Roy, MD, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles; William Swartz, MD, Department of Obstetrics and Gynecology, University of California, San Diego; Tom Madhavan, MD, Department of Internal Medicine, Providence Hospital, Southfield, Mich; David E. Soper, MD, Department of Obstetrics and Gynecology, Medical College of Virginia, Richmond; S. Gene McNeeley, MD, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor; Richard L. Sweet, Department of Department of Obstetrics and Gynecology, University of California, San Francisco; Donald S. Horner, MD, Department of Department of Obstetrics and Gynecology, The Nalle Clinic, Charlottee, NC; Perry L. Fulcher, MD, Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston; William J. McGanity, MD, Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston; and Arnold J. Friedman, Department of Obstetrics and Gynecology, George Washington University, Washington, DC.

Abstract

A multicenter randomized comparative trial was done to assess the safety and efficacy of oral ofloxacin (400 mg twice daily for 10 days) versus cefoxitin (2 g intramuscularly) followed by doxycycline (100 mg twice daily orally for 10 days) for the outpatient treatment of uncomplicated pelvic inflammatory disease (PID). Neisseria gonorrhoeae(GC) grew on pretreatment endocervical cultures from 43 of 268 women (16%), and in 30 of 247 women (12%) cultures were positive for Chlamydia trachomatis(Ct). Ninety-five percent (122/128) of the women treated with the ofloxacin regimen and 93% (112/121) of those treated with the cefoxitin/doxycycline regimen had cure or improvement on examination at a minimum of one follow-up visit. All GC species were eradicated by both ofloxacin and cefoxitin. Among women who returned for follow-up, the eradication of C trachomatis was 88% (15/17) for the cefoxitin/ doxycycline group and 100% (18/18) for ofloxacin. Side effects were more prevalent in the cefoxitin/ doxycycline group (15%) than in the ofloxacin group (7%), nausea/vomiting being the most frequent adverse effect. In this study, it appears that ofloxacin and cefoxitin/doxycycline have similar clinical effectiveness for the outpatient treatment of uncomplicated pelvic inflammatory disease.

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