A Study of Ceftobiprole in Patients With Fever and Neutropenia.
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|ClinicalTrials.gov Identifier: NCT00529282|
Recruitment Status : Terminated (Study discontinued due to administrative reasons unrelated to safety)
First Posted : September 14, 2007
Results First Posted : March 29, 2010
Last Update Posted : August 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fever Neutropenia Gram-positive Bacterial Infections Pseudomonas Infection||Drug: Ceftobiprole Medocaril Drug: Cefepime with or without vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Randomized, Double-Blind Study of Ceftobiprole Versus Comparators in the Treatment of Patients With Fever and Neutropenia|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Ceftobiprole Medocaril 500 mg every 8 hours 120-minute infusion [250 mL]
Drug: Ceftobiprole Medocaril
500 mg every 8 hours
Active Comparator: 002
Cefepime with or without vancomycin 2 g every 8 hrs-30 min infusion vancomycin 1 000mg every 12 hrs-60 min infusion
Drug: Cefepime with or without vancomycin
120-minute infusion [250 mL]
- 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. ]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
- Clinical Cure Regardless of Modification of Therapy [ 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. ]To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).
- Clinical Success at 72 Hours [ Time Frame: 72 hours after starting study drug ]To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin
- Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug [ 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. ]To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529282
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|