Three days of pivmecillinam or norfloxacin for treatment of acute uncomplicated urinary infection in women.
Pivmecillinam is a unique beta-lactam antimicrobial that has been used for the treatment of acute uncomplicated urinary infection for > 20 y. Since this agent was introduced, the quinolone antimicrobials have become widely used for the same indication. This study compared the efficacy of a 3-d regimen of pivmecillinam 400 mg b.i.d. with norfloxacin 400 mg b.i.d. Women aged between 18 and 65 y presenting with symptoms of acute cystitis of < 7 d duration were eligible for enrollment; 483 were randomized to receive pivmecillinam and 471 to receive norfloxacin. In each group, 30% of women had negative urine cultures prior to therapy. Bacteriologic cure at early post-therapy follow-up was achieved in 222/298 (75%) pivmecillinam patients and 276/302 (91%) norfloxacin patients [p < 0.001; 95% confidence interval (CI) 12.0-21.8]. Clinical cure/improvement at Day 4 following initiation of therapy was observed in 434/457 (95%) women who received pivmecillinam and 425/442 (96%) who received norfloxacin (p = 0.39; 95% CI 1.5-3.9). Early post-therapy (11 +/- 2 d) clinical cure was achieved in 360/437 women (82%) who received pivmecillinam and 381/433 (88%) who received norfloxacin (p = 0.019; 95% CI 0.9-10.3). In women aged < or = 50 y, early clinical cure rates were 294/351 (84%) for pivmecillinam and 299/340 (88%) for norfloxacin (p = 0.11; 95% CI 1.0-9.4). Adverse effects were similar for both regimens, and there was no evidence of the emergence of organisms of increasing resistance with therapy. Short-course therapy with norfloxacin was superior to that with pivmecillinam in terms of bacteriologic outcome, although differences in clinical outcome were less marked. In conclusion, short-course therapy with pivmecillinam is an effective empirical treatment for pre-menopausal women.
Nicolle
L E
LE
Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada. lnicolle@hsc.mb.ca
Madsen
K S
KS
Debeeck
G O
GO
Blochlinger
E
E
Borrild
N
N
Bru
J P
JP
Mckinnon
C
C
O'Doherty
B
B
Spiegel
W
W
Van Balen
F A M
FA
Menday
P
P
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000561:Amdinocillin Pivoxil / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D009643:Norfloxacin / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use*; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy*
D000890:Anti-Infective Agents; D010406:Penicillins; D000561:Amdinocillin Pivoxil; D009643:Norfloxacin