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

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 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


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

Value
https://center6.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