A Study of Ceftobiprole in Patients With Fever and Neutropenia.

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Treatments: Cefepime; Ceftobiprole; Ceftobiprole medocaril; Cephalosporins; Vancomycin

Criteria

Inclusion Criteria:

• Patients with neutropenia and fever associated with administration of chemotherapy for cancer that requires intravenous therapy with antibiotics.

Exclusion Criteria:

• Patients who have received antibacterial (oral or intravenous ) treatment for more than 24 hours for fever and neutropenia or have received systemic antibacterial therapy in the previous 72 hours for a defined infectious disease

• Patients with known or suspected hypersensitivity to any related anti-infective

• patients with hepatic impairment

• Patients with severe renal impairment

• Patients who are pregnant or lactating

• Patients who are likely to require major surgical intervention for infection.