In order to evaluate the efficacy and safety of a new aminoglycoside antibiotic, 3′, 4′-dideoxykanamycin B (DKB), in urinary tract infections, a controlled trial with gentamicin (GM) as the reference standard was carried out by double-blind technique at 11 institutions throughout Japan. From the results obtained, the following conclusions were drawn:
(1) With respect to the allocation of GM and DKB, there was no serious bias in favor of ither drug in the entire series of 148 cases studied, or in the divided subgroups with and without cystitis.
(2) Global judgement made at participating institutions was substantially in accordance with the general plan described in the study protocol: emphasis was placed on bacteriuria turning negative, with consideration given to whether and to what extent pollakiuria and urine sediment findings were improved.
(3) No difference in clinical significance was observed on an average basis between the global judgement for GM and that for DKB as assessed in the entire series (statistically P=0.7969) or in subgroups with and without cystitis.
(4) Untoward reactions were observed somewhat more frequently in patients treated with GM (P=0.1078).
