Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00529282
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2007-09-11
Brief Title:
A Study of Ceftobiprole in Patients With Fever and Neutropenia
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
Multicenter Randomized Double-Blind Study of Ceftobiprole Versus Comparators in the Treatment of Patients With Fever and Neutropenia
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinued due to administrative reasons unrelated to safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CEFTOFBN3004 | None | None | None |