Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
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| ClinicalTrials.gov Identifier: NCT00137787 |
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Recruitment Status :
Completed
First Posted : August 30, 2005
Last Update Posted : June 26, 2018
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Sponsor:
Center for Supporting Hematology-Oncology Trials
Collaborator:
Bayer
Information provided by (Responsible Party):
Center for Supporting Hematology-Oncology Trials
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Febrile Neutropenia | Drug: ciprofloxacin Drug: cefepime | Phase 3 |
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, i.e., 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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases |
| Actual Study Start Date : | April 2005 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | May 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cyclic neutropenia
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: ciprofloxacin |
| Active Comparator: 2 |
Drug: cefepime |
Primary Outcome Measures :
- Treatment efficacy [ Time Frame: At 7 days after initiating therapy ]
Secondary Outcome Measures :
- Treatment efficacy [ Time Frame: At 21 days ]
- Toxicity [ Time Frame: During the follow-up period ]
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| Ages Eligible for Study: | 15 Years to 79 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hematologic disease
- Ages between 15 and 79 years
- Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting for more than 1 hour
- Absolute neutrophil count of less than 500/microL
- T-Bil level less than 2.0 times the upper limit of normal
- Cre level less than 1.5 times the upper limit of normal
- Written informed consent
Exclusion Criteria:
- Past history of allergic reaction to the study drug
- Positive for HIV antibody
- Pregnant or lactating women
- Family history of auditory disturbance
- Having received systemic antibacterial therapy within 14 days
- Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation
- No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode
- On treatment with ketoprofen
- On treatment with sodium valproate
- Septic shock
Information from the National Library of Medicine
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): NCT00137787
Locations
| Japan | |
| Nagoya University Graduate School of Medicine | |
| Nagoya, Japan, 466-8550 | |
Sponsors and Collaborators
Center for Supporting Hematology-Oncology Trials
Bayer
Investigators
| Study Director: | Yoshiko Atsuta, MD | Nagoya University |
Publications of Results:
| Responsible Party: | Center for Supporting Hematology-Oncology Trials |
| ClinicalTrials.gov Identifier: | NCT00137787 |
| Other Study ID Numbers: |
C-SHOT 0402 |
| First Posted: | August 30, 2005 Key Record Dates |
| Last Update Posted: | June 26, 2018 |
| Last Verified: | June 2018 |
Keywords provided by Center for Supporting Hematology-Oncology Trials:
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febrile neutropenia hematologic disease |
Additional relevant MeSH terms:
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Neutropenia Hematologic Diseases Febrile Neutropenia Fever Agranulocytosis Leukopenia Leukocyte Disorders Body Temperature Changes Ciprofloxacin Cefepime |
Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |