Carumonam as prophylaxis against bacterial infection in neutropenic children with malignancy

Abstract

The efficacy and safety of carumonam and G-CSF were compared with those of historical controls for prophylaxis against bacterial infection in neutropenic children with malignancy. All patients were administered antibiotics by nebuliser (amphotericin B and tobramycin) and orally (amphotericin B or fluconazole and sulfamethoxazole/trimethoprim). The incidence of febrile episodes (body temperature higher than 38°C) was significantly lower in group C patients (both carumonam- and G-CSF-treated, 32%, 1.0±1.9 days) than in group A patients (neither carumonam- nor G-CSFtreated, 82%, 5.2±3.5 days) and group B patients (only G-CSF-treated, 78%, 2.9±1.9 days). Although the duration of neutropenia (neutrophil count lower than 250/μl) was shortest in group B, there was no difference in the minimum neutrophil count in these three groups. Fewer carumonam-treated patients (group C) experienced microbiologically documented infections compared with patients treated without carumonam (groups A and B). There were no serious adverse reactions associated with Carumonam that required discontinuation of the medication. These results suggest that carumonam is both safe and effective in preventing serious bacterial infection in neutropenic patients.