A randomized, controlled trial of cefoperazone vs. cefamandole-tobramycin in the treatment of putative, severe infections with gram-negative bacilli.

Cefoperazone was compared with the combination of cefamandole and tobramycin in a prospective, randomized study of putative, severe, gram-negative bacillary infections. We attempted to exclude patients with granulocytopenia or infections due to Pseudomonas species. A total of 118 isolates (94 gram-negative bacilli and 24 gram-positive cocci) caused infection in 99 of the 120 patients studied. Cefoperazone (16 micrograms/ml) was active against 93% of the organisms tested; cefamandole (16 micrograms/ml) and/or tobramycin (4 micrograms/ml) was active against 95%. Infection was cured or improved in 77% of cefoperazone-treated patients and 81% of cefamandole-tobramycin-treated patients. Bacteremia was cured or improved in 61% of cefoperazone-treated patients and in 63% of cefamandole-tobramycin-treated patients. Adverse reactions included five cases of probable antibiotic-associated nephrotoxicity in the cefamandole-tobramycin group; there were no such cases in the cefoperazone group. One patient given cefoperazone plus eight other drugs became granulocytopenic, but the condition resolved when all medications were stopped. This analysis suggests that cefoperazone alone may be as effective as cefamandole plus tobramycin in the treatment of severe infections with gram-negative bacilli and is less nephrotoxic. The role of cefoperazone in patients with granulocytopenia or infections due to Pseudomonas aeruginosa was not evaluated.

RCT Entities:   Population Interventions Outcomes