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

Phase 3 Completed 51 enrolled Center for Supporting Hematology-Oncology Trials Bayer · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-04
Primary completion: 2009-12
Completion: 2010-05

Outcome

Missed primary endpoint

paper We could not prove the non-inferiority of CPFX in comparison with CFPM for the initial treatment of FN. PMID 23317527 ↗

Publications

Results Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cefepime	Small molecule	2 g	Intravenous
Subject	Ciprofloxacin	Small molecule	300 mg	Intravenous