@article {Irving:December 2001:0002-8614:1606, author = "Irving H. Gomolin", author = "Paul F. Siami", author = "Jonathan Reuning-Scherer", author = "Daniel C. Haverstock", author = "Allen Heyd", author = "the Oral Suspension Study Group", title = "Efficacy and Safety of Ciprofloxacin Oral Suspension Versus Trimethoprim-Sulfamethoxazole Oral Suspension for Treatment of Older Women with Acute Urinary Tract Infection", journal = "Journal of the American Geriatrics Society", volume = "49", year = "December 2001", abstract = "J Am Geriatr Soc 49:16061613, 2001. OBJECTIVES:
To compare the efficacy and safety of ciprofloxacin (CIP) oral suspension to trimethoprim/sulfamethoxazole (TMP/SMX) oral suspension among older women with acute urinary tract infections (UTIs). DESIGN: Prospective, randomized, open-label, multicenter study of older women (age 65 and older). SETTING: Community and nursing home. PARTICIPANTS: A total of 261 older women were evaluable for safety. Of these, 172 (86 community, 86 nursing home) were evaluable for clinical and bacteriological efficacy. INTERVENTION: Patients were randomized to a 10-day regimen of either CIP (250mg/5mL twice daily) or TMP/SMX (160/800mg/20mL twice daily). MEASUREMENTS: Clinical response 4 to 10 days posttherapy. RESULTS: For the efficacy-valid population, posttherapy clinical resolution was statistically superior following CIP (97%) versus TMP/SMX (85%) (95% CI = 2.021.3; P = .009). Eradication of pretreatment bacterial isolates posttherapy was also higher following CIP (95%) versus TMP/SMX (84%) (95% CI = 2.721.3; P = .019). For the intent-to-treat population, posttherapy clinical resolution was significantly higher in the CIP group (96%) than in the TMP/SMX group (87%) (95% CI = 0.216.7; P = .025). Safety was assessed in the intent-to-treat population and the incidence of drug-related adverse events were significantly lower following CIP (17%) than following TMP/SMX (27%) (P = .047). Premature discontinuation due to these events was also less prevalent with CIP than with TMP/SMX (2% vs 11%, respectively) (P = .004). CONCLUSION: CIP suspension showed higher clinical success and bacteriological eradication rates than did TMP/SMX for both community-based and nursing homeresiding older women with acute UTIs. Furthermore, CIP suspension was associated with significantly lower rates of adverse events and premature discontinuations compared with TMP/SMX suspension.", pages = "1606-1613(8)", url = "http://www.ingentaconnect.com/content/bsc/jgs/2001/00000049/00000012/art00004" }