Open randomized controlled parallel study of ofloxacin versus trimethoprim-sulfamethoxazole treatment of lower respiratory tract and urinary infections.

A total of 60 patients with lower respiratory tract or urinary tract infections were enrolled in an open, randomized, controlled, parallel study comparing 300 mg ofloxacin (OFX) b.i.d. with trimethoprim + sulfamethoxazole (TMP 800 mg + SMX 160 mg), 1 tablet, b.i.d. The signs and symptoms of low respiratory tract infection were cured in 12 patients (80%) of the OFX group and improved in 2 other patients (13%); at the end of therapy, the 2 germs that persisted were Streptococcus pneumoniae and Branhamella catarrhalis. Clinical cure was achieved in 13 patients (86%) in the TMP-SMX group, while 2 patients were considered as failures (14%); after therapy, the 3 organisms that persisted were 2 S. pneumoniae and 1 Pseudomonas aeruginosa. As far as urinary tract infections are concerned clinical cure and complete eradication of bacteria were achieved in 14 patients in the OFX group (93%); the germ that persisted was Escherichia coli (100,000 CFU), but the patient was asymptomatic. In patients of the TMP-SMX group the urinary infections were cured in 11 subjects (73%); the germs that persisted were 2 E. coli and 1 Proteus mirabilis. Adverse effects were reported for 3 patients (10%) in the OFX group and 4 patients (13%) in the TMP-SMX group. The measurement of serum and intracellular (polymorphonuclear cells and lymphocytes) levels of OFX and TMP-SMX and the assessment of the host's immunocompetence ruled out the possibility of any immunotoxicological side effect.