Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00137787 |
Recruitment Status :
Completed
First Posted : August 30, 2005
Last Update Posted : June 26, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Febrile Neutropenia | Drug: ciprofloxacin Drug: cefepime | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: ciprofloxacin |
Active Comparator: 2 |
Drug: cefepime |
- Treatment efficacy [ Time Frame: At 7 days after initiating therapy ]
- Treatment efficacy [ Time Frame: At 21 days ]
- Toxicity [ Time Frame: During the follow-up period ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 79 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Nagoya University Graduate School of Medicine | |
Nagoya, Japan, 466-8550 |
Study Director: | Yoshiko Atsuta, MD | Nagoya University |
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 |
febrile neutropenia hematologic disease |
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 |