To evaluate the clinical efficacy, safety and usefulness of TE-031 in the treatment of pneumonia, We carried out a multi-center double-blind comparative clinical study using midecamycin acetate (MOM) ...as the control drug. TE-031 was administered orally in a daily dosage of 400 mg (in two doses of 200 mg each), while MOM was administered orally in a daily dosage of 600 mg (in three doses of 200 mg each). As a rule, the duration of administration was 14 days. The following results were obtained. 1) The clinical efficacy was judged by the attending committee, and the efficacy rates were 90.2% in the TE-031 group and 73.9% in the MOM group. The clinical efficacy in the TE-031 group was significantly higher. 2) When the clinical efficacy was evaluated by the doctors in charge, the efficacy rates were 91.5% in the TE-031 group and 77.9% in the MOM group. The efficacy rate in the TE-031 group was significantly higher. 3) The bacteriological efficacy rates were 90.5% in the TE-031 group and 76.2% in the MOM group.Although the eradication rate in the TE-031 group was higher, the difference was not statistically significant. 4) The improvement in the signs/symptoms, laboratory test values and chest X-rays was evaluated. The improvement in both body temperature and CRP was significantly superior in the TE-031 group, but none of the other parameters showed any significant differences between the two drug groups. 5) The incidence of side effects was 5.5% in the TE-031 group and 6.5% in the MOM group, while the incidence of laboratory test abnormalities was 12.1% and 9.1%, respectively. These differences were not statistically signifcant. 6) Usefulness, evaluated by the committee, showed satisfactory rates of 86.1% in the TE-031 group and 70.4% in the MOM group, the TE-031 group's rate being significantly higher. In theevaluation by the doctors in charge, the usefulness rates were 86.1% in the TE-031 group and 75.0% in the MOM group but the difference was not found to be statistically significant. 7) On the basis of the results summarized above, it was confirmed that, in comparison with MOM (at 600 mg/day), TE-031 (at 400 mg/day) showed a high degree of clinical usefulness as an antibiotic in the treatment of pneumonia.
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