Results of a newly published study show that initial empiric monotherapy with the antibiotic meropenem(Drug information on meropenem) (Merrem) has positive clinical benefits, is well-tolerated, and is a realistic alternative to standard combination therapy (ceftazidime plus amikacin(Drug information on amikacin)) in the treatment of febrile episodes in neutropenic patients, including those with persistent, profound neutropenia who are at high risk of infection. The study was published in a recent issue of Antimicrobial Agents and Chemotherapy.
Meropenem is a carbapenem antibiotic being developed by Zeneca Pharmaceuticals. The product's new drug application is currently under review by the FDA.
The study, conducted by the European Organization for the Research and Treatment of Cancer-International Antimicrobial Therapy Cooperative Group (EORTC-IATCG) and Gruppo Italiano Malattie Ematologiche Maligne dell' Adulto (GIMEMA) Infection Program, involved over 1,000 patients from 41 centers predominantly in Europe. Its aim was to compare the efficacy and safety of meropenem as monotherapy to that of ceftazadime plus amikacin for the initial empiric treatment of febrile episodes in cancer patients with profoundly persistent neutropenia.
A successful clinical outcome was achieved in 56% (270/483) of the patients who received monotherapy with merepenem, as compared with 52% (245/475) of the patients given the combination regimen. The overall incidence of adverse events considered by the investigators to be drug related was 3.7% (19/516) in patients receiving merepenem and 6.1% (31/511) in those given the combination.
Overall, monotherapy with merepenem was shown to be as clinically beneficial as the combination of antibiotics and was well tolerated in both the adults and a subgroup of children (1 to 16 years old). Notably, merepenem was well tolerated by the central nervous system (no seizures were reported) and by the gastrointestinal tract (minimal nausea/vomiting).