UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)
Acronym	RCT comparing CPFX and CFPM in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)
Scientific Title	Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)
Scientific Title:Acronym	RCT comparing CPFX and CFPM in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)
Region	Japan

Condition
Condition	Febrile neutropenia
Classification by specialty	Hematology and clinical oncology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Treatment efficacy at 7 days after initiating therapy
Key secondary outcomes	Time to achieve defervescence, treatment efficacy at 21 days, toxicity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CPFX 300mg, 1h-div, q12h.
Interventions/Control_2	CFPM 2g, 1h-div, q12h.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Hematologic disease (2) Age between 15 and 79 (3) 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 (4) Absolute neutrophil count of less than 500/microL (5) T-Bil level less than 2.0 times the upper limit of normal (6) Cre level less than 1.5 times the upper limit of normal (7) Written informed consent
Key exclusion criteria	(1) Past history of allergic reaction to the study drug (2) Positive for HIV antibody (3) Pregnant or lactating woman (4) Family history of auditory disturbance (5) Having received systemic antibacterial therapy within 14 days (6) Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation (7) No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode (8) On treatment with ketoprofen (9) On treatment with sodium valproate (10) Septic shock
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoki Naoe
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL	052-744-2145
Email

Public contact
Name of contact person	1st name Middle name Last name Yuichi Ishikawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL	052-744-2145
Homepage URL	http://www.c-shot.or.jp/
Email	yishikaw@med.nagoya-u.ac.jp

Sponsor
Institute	Center for Supporting Hematology-Oncology Trials (C-SHOT)
Institute
Department

Funding Source
Organization	Bayer Pharmaceutics Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00137787
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 08 Month 29 Day

Related information
URL releasing protocol	http://www.c-shot.or.jp/
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/23317527
Number of participants that the trial has enrolled
Results	Fifty-one episodes were included in this trial, and 49 episodes (CPFX vs. CFPM: 24 vs. 25) were evaluated. Treatment efficacy at day 7 was significantly higher in the CFPM group (successful clinical response: nine with CPFX and 19 with CFPM; p=0.007). The response was better in high-risk patients with neutrophil counts of less or equal to 100/microliter (p=0.003). The overall response during the study period was similar between the CPFX and CFPM groups (p=0.64). Adverse events were minimal, and all patients could continue the treatment.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date	2005 Year 05 Month 01 Day
Last follow-up date	2010 Year 01 Month 01 Day
Date of closure to data entry	2010 Year 02 Month 01 Day
Date trial data considered complete	2010 Year 05 Month 01 Day
Date analysis concluded	2010 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 08 Month 29 Day
Last modified on	2013 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000135

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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