A Study of Ceftobiprole in Patients With Fever and Neutropenia.

NCT ID: NCT00529282

Last Updated: 2012-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-01-31

Brief Summary

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

Detailed Description

This study is being discontinued due to issues regarding the comparator, cefepime. In Nov 2007 FDA issued a MedWatch regarding cefepime and the trial was suspended. As of May 14, 2008 the FDA was still evaluating the data on cefepime and final follow up is pending. There were no safety issues with ceftobiprole in this study based on the enrollment of 2 subjects in September of 2007. The study is being discontinued for administrative reasons. Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved, but undergoing regulatory review for treatment of skin infections. This is a randomized (patients are assigned to receive the different treatments under study based on chance), double-blind (neither the patient nor the physician knows whether the drug being investigated or the comparator agent is being taken), multicenter study of treatment with ceftobiprole medocaril versus treatment with a comparator in patients 18 years of age or older, who have fever and neutropenia after chemotherapy for cancer that requires intravenous therapy. Patients will be randomly assigned to receive either ceftobiprole medocaril or comparator. In addition, patients in the comparator group who are at risk of serious infections due to gram-positive pathogens (disease-causing bacteria) may also receive an antibiotic with MRSA activity. The study will consist of the following 3 phases: a prerandomization phase (includes screening and baseline assessments); a treatment phase, and a follow-up phase consisting of a primary efficacy visit and a late follow-up visit. The primary endpoint is the clinical cure rate. The total duration of of the study is determined by the time to resolution of fever and neutropenia and the conditions associated with the episode of fever and neutropenia. This is followed by the primary efficacy visit (7 to 10 days after the end of therapy) and the late follow-up visit (28 to 35 days after the end of treatment). Cultures (samples of blood or other suspected sites of infection) will be collected during the study as well as blood samples for hematology and chemistry (safety assessments). All adverse events will also be reported throughout the study and for about 4 to 5 weeks after the last dose of study drug. Patients will be randomized to either ceftobiprole or comparator for approximately 7 to 14 days.

Conditions

Fever; Neutropenia; Gram-positive Bacterial Infections; Pseudomonas Infection

Keywords

Low numbers of neutrophils in the blood; increased body temperature; cancer chemotherapy; ceftobiprole; pseudomonas infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

001

Ceftobiprole Medocaril 500 mg every 8 hours 120-minute infusion \[250 mL\]

Group Type: EXPERIMENTAL

Ceftobiprole Medocaril

Intervention Type: DRUG

500 mg every 8 hours

002

Cefepime with or without vancomycin 2 g every 8 hrs-30 min infusion vancomycin 1 000mg every 12 hrs-60 min infusion

Group Type: ACTIVE_COMPARATOR

Cefepime with or without vancomycin

Intervention Type: DRUG

120-minute infusion \[250 mL\]

Interventions

Ceftobiprole Medocaril

500 mg every 8 hours

Intervention Type: DRUG

Cefepime with or without vancomycin

120-minute infusion \[250 mL\]

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries

Belgium; Hungary; Mexico; Portugal; Russia; South Africa; Spain; Ukraine; United States

Other Identifiers

CEFTOFBN3004

Identifier Type: -

Identifier Source: secondary_id

CR014206

Identifier Type: -

Identifier Source: org_study_id