Cefoperazone: an analysis of results in the pediatric population from a post-marketing surveillance study in hospitalized patients. The Cefoperazone Collaborative Post-marketing Surveillance Study Group.

Abstract

The injectable third-generation cephalosporin, cefoperazone, was introduced in India in early 1994. A post-marketing surveillance study was conducted in 1994-95 to collect local data on efficacy and safety, evaluate the native pattern of bacterial susceptibility, and assess the relationship of in vitro susceptibility tests to clinical efficacy. Hospitalized patients with features suggestive of infections that are approved indications for cefoperazone were eligible for the study. This report presents an analysis of the results among patients in the pediatric age group. The recommended dose range for children was 50-200 mg/kg/day. At analysis, 95 patients aged 6 days to 14 years were evaluable for efficacy. About a third of these (31%) were judged to have hospital acquired infections, and 22 (23%) had failed prophylaxis or previous treatment. A successful clinical outcome was observed in 91% of 75 non-neutropenic patients. Eighteen (95%) of 19 patients with pneumonia and 8 (89%) of 9 patients with pyogenic meningitis responded to cefoperazone. Five of 6 patients with complicated or hospital-acquired upper urinary tract infections, 2 of 3 patients with peritonitis, and all patients with skin or soft tissue infections, intra-abdominal abscess, osteomyelitis, and brain abscess also responded. Four of 5 non-neutropenic patients with septicemia recovered with cefoperazone monotherapy. The response rate was 70% among 20 neutropenic patients, 16 of whom were deemed septicemic. Antibiotic disc susceptibility data among pediatric patients was available for 63 isolates and 13% were reported resistant to cefoperazone. Microbiologic eradication was reported with 94% of initial isolates. Mild to moderate adverse events of study, drug-related or uncertain causation occurred in 4 (3.7%) of patients.