Cefepime clinical studies: Difference between revisions
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===Febrile Neutropenic Patients=== | ===Febrile Neutropenic Patients=== | ||
Revision as of 17:27, 26 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Febrile Neutropenic Patients
The safety and efficacy of empiric cefepime monotherapy of febrile neutropenic patients have been assessed in two multicenter, randomized trials comparing cefepime monotherapy (at a dose of 2 g intravenously every 8 hours) to ceftazidime monotherapy (at a dose of 2 g intravenously every 8 hours). These studies comprised 317 evaluable patients.
| Total | Cefepime | Ceftazidime |
| 164 | 153 | |
| Median age (yr) | 56 (range, 18 to 82) | 55 (range, 16 to 84) |
| Male | 86 (52%) | 85 (56%) |
| Female | 78 (48%) | 68 (44%) |
| Leukemia | 65 (40%) | 52 (34%) |
| Other hematologic malignancies | 43 (26%) | 36 (24%) |
| Solid tumor | 54 (33%) | 56 (37%) |
| Median ANC nadir (cells/microliter) | 20 (range, 0 to 500) | 20 (range, 0 to 500) |
| Median duration of neutropenia (days) | 6 (range, 0 to 39) | 6 (range, 0 to 32) |
| Indwelling venous catheter | 97 (59%) | 86 (56%) |
| Prophylactic antibiotics | 62 (38%) | 64 (42%) |
| Bone marrow graft | 9 (5%) | 7 (5%) |
| SBP less than 90 mm Hg at entry | 7 (4%) | 2 (1%) |
ANC = absolute neutrophil count; SBP = systolic blood pressure
Table 9 describes the clinical response rates observed. For all outcome measures, cefepime was therapeutically equivalent to ceftazidime.
Insufficient data exist to support the efficacy of cefepime monotherapy in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia). No data are available in patients with septic shock.
Complicated Intra-Abdominal Infections
Patients hospitalized with complicated intra-abdominal infections participated in a randomized, double-blind, multicenter trial comparing the combination of cefepime (2 g every 12 hours) plus intravenous metronidazole (500 mg every 6 hours) versus imipenem/cilastatin (500 mg every 6 hours) for a maximum duration of 14 days of therapy. The study was designed to demonstrate equivalence of the two therapies. The primary analyses were conducted on the protocol-valid population, which consisted of those with a surgically confirmed complicated infection, at least one pathogen isolated pretreatment, at least 5 days of treatment, and a 4 to 6 week follow-up assessment for cured patients. Subjects in the imipenem/cilastatin arm had higher APACHE II scores at baseline. The treatment groups were otherwise generally comparable with regard to their pretreatment characteristics. The overall clinical cure rate among the protocol-valid patients was 81% (51 cured/63 evaluable patients) in the cefepime plus metronidazole group and 66% (62/94) in the imipenem/cilastatin group. The observed differences in efficacy may have been due to a greater proportion of patients with high APACHE II scores in the imipenem/cilastatin group.