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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000083
Receipt No. R000000135
Scientific Title Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)
Date of disclosure of the study information 2005/08/29
Last modified on 2013/11/23

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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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