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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Febrile neutropenia | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | CPFX 300mg, 1h-div, q12h. | |
Interventions/Control_2 | CFPM 2g, 1h-div, q12h. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Eligibility | ||||
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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. |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |