Moxalactam therapy vs. standard antimicrobial therapy for selected serious infections.

Moxalactam was studied in a prospective randomized clinical trial in 97 hospitalized patients suspected of having infection caused by moxalactam-susceptible bacteria. Seventy-eight of the 97 patients had clinical and/or bacteriologic evidence of infection, including pneumonia, cellulitis, urinary tract infection, bacteremia, and fever in neutropenic patients. Patients in the control group received antibiotics deemed appropriate by the attending physicians, whereas the moxalactam-treated group received only the study drug. Successful treatment was defined as the resolution of illness sufficient to allow discontinuation of parenteral antibiotic therapy. No significant difference was seen in efficacy with 33 (86.8%) of 38 patients in the moxalactam-treated group and 32 (80%) of 40 in the control group treated successfully (P greater than 0.20). The mean number of febrile days was significantly less in the moxalactam-treated group than in the control group (P less than 0.05). Renal toxicity occurred more frequently in the control group (P = 0.036). Fungal superinfection developed in two patients in the control group and in one in the moxalactam-treated group. An enterococcal superinfection of the bloodstream developed in one patient treated with moxalactam. Thus moxalactam appears to be comparable in efficacy to combinations of antibiotics in the treatment of selected seriously ill patients and may have less renal toxicity.

RCT Entities:   Population Interventions Outcomes