Multicenter, Randomized, Double-Blind Study of Ceftobiprole Versus Comparators in the Treatment of Patients With Fever and Neutropenia
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject's fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated
7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration