Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137787
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2005-08-28
Brief Title:
Comparing Ciprofloxacin CPFX With Cefepime CFPM in Febrile Neutropenic Patients With Hematologic Diseases
Sponsor:
Center for Supporting Hematology-Oncology Trials
Organization:
Center for Supporting Hematology-Oncology Trials
Study Overview
Official Title:
Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases
Detailed Description:
Infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia As for initial therapeutic agents beta-lactam antibiotics ie third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action However under these conditions development of resistance mediated by a beta-lactamase is concerned and there is a need for alternative non-beta-lactam antibiotics for this indication Ciprofloxacin is a potent agent covering against wide range of strains including Pseudomonas aeruginosa and expected as a potential candidate We have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients
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