Pivmecillinam versus sulfamethizole for short-term treatment of uncomplicated acute cystitis in general practice: a randomized controlled trial.
OBJECTIVE
To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI).


METHODS
Randomized controlled trial.


METHODS
General practice, Denmark.


METHODS
Patients (n = 167) with uncomplicated UTI confirmed by positive urine phase-contrast microscopy.


METHODS
Drug efficacy based on clinical and bacteriological cure.


RESULTS
Urinary symptoms disappeared first in patients treated with pivmecillinam, but after five days there was no significant difference in clinical cure rate between the two antibiotics. At the follow-up visit 7-10 days after initiation of treatment, 95.4% of patients treated with pivmecillinam and 92.6% of patients treated with sulfamethizole had no persistent cystitis symptoms (difference 2.8%, CI -4.5%; 10.0%). Bacteriological cure was observed in 68.8% of patients randomized to pivmecillinam and in 77.9% randomized to sulfamethizole (difference -9.2%, CI -24.7%; 6.3%). Some 26.8% of patients randomized to pivmecillinam experienced a new UTI within 6 months after treatment compared with 18.4% of patients randomized to sulfamethizole (difference 8.4%, CI -4.5%;21.4%). No patients developed septicaemia with urinary pathogens within one year after initial treatment.


CONCLUSIONS
Patients treated with a three-day regime of pivmecillinam experienced faster relief of symptoms compared with patients treated with a three-day regime of sulfamethizole. Five days after initiation of treatment there was no significant difference in clinical and bacteriological cure between the two antibiotic regimes.
Bjerrum
Lars
L
Research Unit for General Practice, University of Southern Denmark, J.B. Winsløws Vej 9 A, Odense C, Denmark. lbjerrum@health.sdu.dk
Gahrn-Hansen
Bente
B
Grinsted
Per
P
D000293:Adolescent; D000328:Adult; D000561:Amdinocillin Pivoxil / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage / Q000627:therapeutic use*; D003556:Cystitis / Q000188:drug therapy* / Q000382:microbiology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D013419:Sulfamethizole / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000892:Anti-Infective Agents, Urinary; D000561:Amdinocillin Pivoxil; D013419:Sulfamethizole