Trimethoprim-Sulfamethoxazole in the Treatment of Bacterial Infections: Report of Clinical Trials in Japan

Abstract
The clinical efficacy of trimethoprim-sulfamethoxazole (TMP-SMZ) was assessed in a cooperative study by members of the Japan Society of Chemotherapy. Double-blind comparative clinical trials using TMP-SMZ and SMZ alone indicated that the former is significantly superior to the sulfonamide alone in the treatment of acute urinary tract infections and acute purulent otitis media. Open clinical trials with TMP-SMZ in infections of various organ systems in a large number of patients gave results that roughly corresponded to the experience reported in the literature. These therapeutic results confirm the effect of TMP-SMZ in infections caused by microorganisms both sensitive and resistant to sulfonamides in vitro. Careful hematologic follow-up did not record grave or irreversible untoward reactions during these trials.