Ceftriaxone

James B Kahn, MD(*); Barbara A Wiesinger BSN; Margaret P Oross, BSN, MHSA and William H Olson, PhD. Ortho-McNeil Pharmaceutical, Raritan, NJ.

PURPOSE: This multicenter, randomized, open-label study was designed to compare the efficacy and safety of levofloxacin (LVX) with comparator (C) (ceftriaxone and erythromycin followed by clarithromycin and amoxicillin/clavulanate) in the treatment of serious community-acquired pneumonia (CAP) in adults.

METHODS: Patients were required to be a minimum of 18 years of age and have a diagnosis of serious CAP defined as meeting at least three ATS criteria for hospitalization plus a requirement for mechanical ventilation or other key clinical criteria. A total of 269 patients were enrolled.

RESULTS: Data evaluated to date include 82 patients who completed the posttherapy visit or discontinued according to protocol requirements. The two study arms were generally comparable-by race, gender, age, smoking history, and Apache II scores. The. clinical success rate at posttherapy for clinically evaluable patients was 88.9% in the LVX group compared to 79.2% in the C group. The posttherapy microbiologic eradication rate in the microbiologically evaluable population was 85.7% in the LVX group and 85.7% in the C group. No resistance to LVX was observed. Resistance to the control arm drugs was as follows: ceftriaxone (6.3%), erythromycin (11.1%), clarithromycin (9.4%), and amoxicillin/ clavulanate (12.9%). Adverse events were similar among treatment groups. In LVX-treated patients, constipation, and insomnia were reported more frequently than in C-treated patients, while nausea and diarrhea occurred more frequently in C-treated patients. Six patients (1-LVX, 5-C) were discontinued from the study due to an adverse event. Twenty-two patients (10-LVX, 12-C) experienced one or more serious adverse events. The overall mortality rate for these 82 patients was 10.9%, reflective of a seriously ill population.

CONCLUSION: While there were too few patients to demonstrate statistical equivalence, results from this interim report indicate that LVX 500mg q24h appears at least as effective as traditional combination therapy in the treatment of serious CAP. Complete results from this trial will be presented.

CLINICAL IMPLICATIONS: Levofloxacin is safe and effective in the treatment of hospitalized patients in serious CAP.

COPYRIGHT 2000 American College of Chest Physicians
COPYRIGHT 2001 Gale Group