Efficacy and safety of ciprofloxacin oral suspension versus trimethoprim-sulfamethoxazole oral suspension for treatment of older women with acute urinary tract infection.
OBJECTIVE
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).


METHODS
Prospective, randomized, open-label, multicenter study of older women (age 65 and older).


METHODS
Community and nursing home.


METHODS
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.


METHODS
Patients were randomized to a 10-day regimen of either CIP (250 mg/5 mL twice daily) or TMP/SMX (160/800 mg/20 mL twice daily).


METHODS
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=2.0-21.3; P= .009). Eradication of pretreatment bacterial isolates posttherapy was also higher following CIP (95%) versus TMP/SMX (84%) (95% CI=2.7-21.3; 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=0.2-16.7; 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).


CONCLUSIONS
CIP suspension showed higher clinical success and bacteriological eradication rates than did TMP/SMX for both community-based and nursing home-residing 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.
Gomolin
I H
IH
Gurwin Jewish Geriatric Center, Commack, New York 11725, USA.
Siami
P F
PF
Reuning-Scherer
J
J
Haverstock
D C
DC
Heyd
A
A
D000208:Acute Disease; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000892:Anti-Infective Agents, Urinary / Q000009:adverse effects* / Q000627:therapeutic use; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009735:Nursing Homes; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D013535:Suspensions; D013997:Time Factors; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage* / Q000627:therapeutic use; D014552:Urinary Tract Infections / Q000188:drug therapy*
D000890:Anti-Infective Agents; D000892:Anti-Infective Agents, Urinary; D013535:Suspensions; D002939:Ciprofloxacin; D015662:Trimethoprim, Sulfamethoxazole Drug Combination