Clinical evaluation of pivmecillinam in intractable urinary-tract infections with complications. A comparative study with amoxicillin by a randomized double-blind technique.

A comparative study was made by the double-blind technique in order to make clear the usefulness of pivmecillinam in the treatment of intractable complicated urinary-tract infections using amoxicillin as a reference drug. Pivmecillinam was given in dosage of 400 mg (potency) per day which was one-fifth the dose of amoxicillin 2,000 mg (potency) per day. In global judgement, pivmecillinam was found superior to amoxicillin. It showed a "significant" superiority over amoxicillin for the treatment of, among others, the urinary-tract infections after prostatectomy, which are intractable diseases. When evaluated by symptoms, pivmecillinam improved bacteriuria "significantly" better than amoxicillin. When seen by causative organisms, the pivmecillinam treatment was "significantly" superior to the amoxicillin treatment against E. coli infections. Pivmecillinam was active against amoxicillin-resistant E. coli. Incidence of adverse reactions was less frequent with pivmecillinam than with amoxicillin. These results indicate that pivmecillinam is a drug of high usefulness for the treatment of intractable complicated urinary-tract infections when evaluated using amoxicillin as a reference drug.

RCT Entities:   Population Interventions Outcomes