UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006131 |
|---|---|
| Receipt number | R000007251 |
| Scientific Title | A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia. |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2011/08/24 19:37:40 |
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Basic information
Public title
A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.
Acronym
Oral fluoriquinolones and aminopenicillins versus intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.
Scientific Title
A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.
Scientific Title:Acronym
Oral fluoriquinolones and aminopenicillins versus intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.
Region
| Japan |
Condition
Condition
Childhood cancer
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Non-inferiority efficacy comparison of oral fluoriquinolones and aminopenicillins versus intravenous 4th-generation Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Treatment success rate defined as resolution rate of febrile neutropenia without change of treatment regimen
Key secondary outcomes
Duration of fever, Positive rates of blood cultures, Rates of adverse events, Rates of recurrence of fever
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tosufloxacin + Amoxicillin/clavulanate (oral)
Interventions/Control_2
Cefepime (intravenous)
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
| 1 | years-old | <= |
Age-upper limit
| 19 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed as pediatric cancer with age 1 to 19 years
2)Febrile (1 episode of axillary temperature above 38.3 degrees or 2 episodes of 38 degrees taken on two occasions at least 1 hour apart within the last 24 hours )
3) Absolute neutrophil count (ANC)
less than 1000/microliter (band cell + segmented cell) in peripheral blood sample within 3 days including the day of developing fever
4)Informed consent is taken by substitute and the patient over 16 years old in writing
Key exclusion criteria
1) patients who has a history of stem cell transplantation
2) acute leukemia or lymphoma patients who are under induction or consolidation chemotherapy
3) patients with suspected central venous catheter-related infection
4) patients with consciousness disturbance (under 15 points of pediatric Glasgow coma scale)
5) patients with hypotension
6) patients with hypoxemia (SpO2 less than 95% by pulse oximeter under the room air)
7) patients with apparent active infection
8) patients with nausea and vomiting expected difficult to take internal medicine
9) patients of organ failure (Grade3 or 4 level in NCI CTCAE, such as Hyperbilirubinemia,elevated alanine aminotransferase,elevated aspartate aminotransferase,elevated serum creatinine)
10) patients administrated other antibiotics (except sulfamethoxazole/trimethoprim as prophylaxis against pneumocystis carinii)
11) patients with hypersensitivity
against Tosufloxacin, Amoxicillin/clavulanate,and cefepime
12) pregnant patients or those who are suspected pregnancy
13) patients who are considered inappropriate to join this study by the physicians
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kaneko |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Hematology and Oncology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, TOKYO, JAPAN
TEL
042-300-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Tsuji |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Hematology and Oncology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, TOKYO, JAPAN
TEL
042-300-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立小児総合医療センター（東京都）,東京都立多摩総合医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 08 | Day |
Last modified on
| 2011 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007251
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