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Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

Information source: Center for Supporting Hematology-Oncology Trials
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Febrile Neutropenia

Intervention: ciprofloxacin (Drug); cefepime (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Center for Supporting Hematology-Oncology Trials

Official(s) and/or principal investigator(s):
Yoshiko Atsuta, MD, Study Director, Affiliation: Nagoya University

Overall contact:
Yoshiko Atsuta, MD, Phone: 81-52-719-1973, Email: y-atsuta@med.nagoya-u.ac.jp

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.

Clinical Details

Official title: Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment efficacy

Secondary outcome:

Treatment efficacy

Toxicity

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, 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.

Eligibility

Minimum age: 15 Years. Maximum age: 79 Years. Gender(s): Both.

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

Locations and Contacts

Yoshiko Atsuta, MD, Phone: 81-52-719-1973, Email: y-atsuta@med.nagoya-u.ac.jp

Nagoya University Graduate School of Medicine, Nagoya 466-8550, Japan; Recruiting
Yoshiko Atsuta, MD, Phone: 81-52-719-1973, Email: y-atsuta@med.nagoya-u.ac.jp
Tomoki Naoe, MD, Principal Investigator
Additional Information

The C-SHOT homepage

Starting date: April 2005
Last updated: November 11, 2008

Page last updated: August 23, 2015

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