Official Title: “Multicenter, Randomized, Double-Blind Study of Ceftobiprole Versus Comparators in the Treatment of Patients With Fever and Neutropenia”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Ceftobiprole Medocaril
  • 500 mg every 8 hours - 120-minute infusion [250 mL]
• Drug: Cefepime w/ or w/o vancomycin
  • 2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
• Active Comparator: 002

Primary Measures

• To determine the clinical cure rate of ceftobiprole vs comparator in patients with fever and neutropenia.
  • Time Frame: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.
    Safety Issue?: No

Secondary Measures

• Safety outcomes include adverse events; clinical laboratory tests, and vital signs and physical examinations.
  • Time Frame: 28 to 35 days after end of therapy
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00529282

Study ID Number: CR014206

ClinicalTrials.gov Identifier: NCT00529282

Health Authority: United States: Food and Drug Administration