Three days of Pivmecillinam or Norfloxacin for Treatment of Acute Uncomplicated Urinary Infection in Women

Abstract

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.

Antibiotic treatment of uncomplicated urinary tract infection in premenopausal women

“…In two studies pivmecillinam was either used as 200 mg for 7 days or as 400 mg bid for 3 days [25,26]. Threeday pivmecillinam was compared with norfloxacin 400 mg bid for 3 days.…”

Susceptibility testing of urinary isolates of Escherichia coli to mecillinam using NCCLS methodology

“…were investigated. Five hundred and sixtyone isolates including 513 E. coli were obtained from two clinical trials [16,17]. The rest were bank isolates selected from a strain collection at Statens Serum Institute, Copenhagen, Denmark.…”

Therapie der akuten unkomplizierten Harnweginfektion

“…Generation oder geschützte Aminopenicilline, d. h. in Kombination mit einem β-Laktamaseinhibitor, verglichen haben, waren für die IDSA-Analyse nicht erhält-lich [6]. Neuere Studien zeigten jedoch, dass 7 Tage Pivmecillinam 200 mg (2-mal/Tag) und 3 Tage Norfloxacin 400 mg (2-mal/Tag) vergleichbar waren [15,16]. Pivmecillinam hatte jedoch eine geringere Rate an vaginaler Candidiasis zur Folge.…”

“…Cefpodoxim [18] 100 mg 2x/Tag 3 Ciprofloxacin a [26,27] 250 mg 2x/Tag 3 Ciprofloxacin XR a [14] 500 mg 1x/Tag 3 Fosfomycin Trometamol [9,20] 3000 mg Einmaldosis 1 Levofloxacin a [33] 250 mg 1x/Tag 3 Nitrofurantoin [7,36] 50-100 mg 3x/Tag 5-7 Nitrofurantoin SR [7,36] 100 mg 2x/Tag 5-7 Norfloxacin a [37,38] 400 mg 2x/Tag 3 Ofloxacin a [39,40,41] 200 mg 2x/Tag 3 Pivmecillinam [15,16,43] 200 mg 2x/Tag 7 Trimethoprim (TMP) a [6,7,44] 200 mg 2x/Tag 5-7 TMP-SMX a [6] 160/800 mg 2x/ Tag …”

“…Üblicherweise wird eine 7-Tage-Therapie empfohlen, z. B. mit Pivmecillinam [54]. Eine Kurzzeittherapie ist nicht etabliert, jedoch gibt es Hinweise auf eine Effektivität als kleineren Studien [55].…”