NIPH Clinical Trials Search

UMIN ID: UMIN000000462

Registered date:04/08/2006

Validation study VI of febrile neutropenia guideline 2004

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedFebrile Neutropenia
Date of first enrollment2005/10/01
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)CFPM 2g, 3h-div, q12h MEPM 1g, 3h-div, q12h IPM/CS 1g, 3h-div, q12h CZOP 2g, 3h-div, q12h


Primary OutcomeTreatment efficacy for 7-day period after antimicrobiral therapy
Secondary OutcomeEfficacy at day 3-5, 14, 30 Safety

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1.Isolation of microorgaism resistant to the study drug 2.Serious cardiac, liver or renal dysfunction 3.Past history of allergy to beta-lactum 4.Allergic diathesis 5.Positive skin reaction to study drug if it has to be done by each institution's regulation 6.Elderly patients who can not be evaluated for efficacy 7.Pregnant or lactating woman 8.Age of 15 years or younger 9.Antimicrobial treatment within 3 months prior to the study entry 10.Allogenic hematopoietic stem cell transplantation and older person 11.Patients to exclude from the study by primary physician's decision

Related Information


public contact
Name Kazuo Tamura
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka Japan
Telephone 092-801-1011
Affiliation Fukuoka University Depatment of Internal Medicine
scientific contact
Name Akihisa Kanamaru
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka Japan
Affiliation Kinki University Department of Hematology