Comparative study of doripenem and meropenem in respiratory infections. Phase III double-blind comparative study

We evaluated the clinical efficacy and safety of doripenem (DRPM), a new carbapenem for injection, in respiratory infection in a randomized, double-blind, 2-group parallel-group, noninferiority comparative study with meropenem (MEPM). The dosage of DRPM was 250 ing 2 times daily for 7 days (DRPM group) and that of MEPM 500 mg 2 times daily for 7 days (MEPM). Results as follows: 1. Clinical efficacy. Subjects evaluated for clinical efficacy numbered 193. Clinical efficacy in the per-protocol-set was 92.7% (89/96) in the DRPM group 90.7% (88/97) in the MEPM group. DRPM thus demonstrated noninferiority to MEPM. 2. Bacteriological effect. About half of the subjects, or 91, evaluated for clinical efficacy were further evaluated for bacteriological effects. Eradication was 86.0% (37/43) in the DRPM group and 95.8% (46/48) in the MEPM group, no significant difference in eradication between groups. 3. Safety. Subjects were evaluated for nonlaboratory adverse drug reactions numbered 218. The incidence of nonlaboratory adverse drug reactions was 8.1% (9/111) in the DRPM group and 6.5% (7/107) in the MEPM group. Of these 217 were further evaluated for laboratory adverse drug reactions. The incidence of laboratory adverse drug reactions was 23.4% (26/111) in the DRPM group and 25.5% (27/106) in the MEPM group, indicating no significant difference in nonlaboratory or laboratory adverse drug reaction incidence. DRPM (250 mg 2 times daily for 7 days) is thus considered to have a novel therapeutic effect comparable to MEPM (500 mg 2 times daily for 7 days).