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Trimethoprim-Sulfamethoxazole for Acute Dysuria in Women: A Single-Dose or 10-Day Course: A Double-Blind, Randomized Trial

STEPHAN D. FIHN, M.D., M.P.H.; CAROLYN JOHNSON, C.R.N.; PACITA L. ROBERTS, M.S.; KATHERINE RUNNING, W.H.C.S.; and WALTER E. STAMM, M.D.
[+] Article and Author Information

Grant support: in part by grant no. AI 18389 from the National Institute of Allergy and Infectious Diseases.

Presented in part at the plenary session of the Society for Research and Education in Primary Care Internal Medicine, Washington, DC, May 1986.

▸Requests for reprints should be addressed to Stephan D. Fihn, M.D., M.P.H.; Medical Comprehensive Care Unit, 111M, Seattle VA Medical Center, 1660 S. Columbian Way; Seattle, WA 98108.


Seattle, Washington


Ann Intern Med. 1988;108(3):350-357. doi:10.7326/0003-4819-108-3-350
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Study Objective: To compare single-dose and 10-day treatment regimens of trimethoprim-sulfamethoxazole in women with acute dysuria, urgency, or urinary frequency.

Design: Double-blind, randomized, placebo-controlled trial.

Setting: Student health center at a major university.

Patients: Consecutive sample of 255 young women including 216 with a bacteriologically documented urinary tract infection.

Intervention: Single-dose treatment (trimethoprim, 320 mg and sulfamethoxazole, 1600 mg) given to 116 women and 10-day treatment (trimethoprim, 160 mg and sulfamethoxazole, 800 mg, twice daily) given to 125 women. Women with a history of sulfonamide allergy were given trimethoprim alone: 10 received single-dose treatment (200 mg) and 5 received 10-day treatment (100 mg, twice daily).

Measurements and Main Results: The rates for resolution of symptoms at 3 days, 13 days, and 6 weeks after entry into the study were not significantly different between treatment groups. Among women with urinary tract infections, cumulative crude rates of recurrence in the single-dose and 10-day treatment groups, respectively, were 24% compared with 5% at 13 days after entry (P = 0.0002; 95% confidence interval [Cl] for difference in proportions, 10%, 28%) and 32% compared with 21% at 6 weeks after entry (P = 0.07; 95% Cl, -2%, 24%). Factors independently associated with lower cure rates were a history of a urinary tract infection within the previous 6 weeks (adjusted odds ratio [OR], 3.8; 95% Cl, 1.4 to 10.6) and presence of 105 bacteria/mL or greater in an initial midstream culture (adjusted OR, 2.9; 95% Cl, 1.2 to 7.0). After controlling for these factors, the risk of failure after single-dose treatment was not statistically significantly different from 10-day treatment at 6 weeks (adjusted OR, 1.6; 95% Cl, 0.8 to 3.2; P = 0.21). Compared to 10-day treatment, single-dose treatment less effectively eradicated Escherichia coli from the vaginal flora (P < 0.001) and led more often to early same-strain recurrences (P = 0.003). Meaningful adverse effects occurred in 12% of women given single-dose treatment compared with 25% of women receiving 10-day treatment (P = 0.009).

Conclusions: Compared with single-dose treatment, 10-day treatment yields a superior cure rate at 2 weeks after the start of treatment, but by 6 weeks the advantage of longer treatment no longer exists. This effect may be explained by the lesser effectiveness of single-dose treatment in eradicating vaginal E. coli, resulting in more frequent same-strain recurrences within 2 weeks of treatment. Adverse effects occur nearly twice as often among patients receiving 10-day treatment. An intermediate duration of treatment, for example, 3 days, may be optimal and should be tested in future studies.

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