UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000083 |
|---|---|
| Receipt number | 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 19:21:22 |
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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
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/
yishikaw@med.nagoya-u.ac.jp
Sponsor or person
Institute
Center for Supporting Hematology-Oncology Trials (C-SHOT)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000135
