Validation study VI of febrile neutropenia guideline 2004

Validation study VI of febrile neutropenia guideline 2004 - Treatment for FN in high-risk patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000462

Enrollment

400

Registered

2006-08-04

Start date

2005-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia

Interventions

CFPM 2g, 3h-div, q12h MEPM 1g, 3h-div, q12h IPM/CS 1g, 3h-div, q12h CZOP 2g, 3h-div, q12h

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Hematologic disease or solid tumor (exclusion of low-risk patients) 2.Absolute neutrophil count of less than 1000/micro L 3.Axillary temperature greater than 37.5 4.The patients who have possible infections precess

Exclusion criteria

Exclusion criteria: 1.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

Design outcomes

Primary

Measure	Time frame
Treatment efficacy for 7-day period after antimicrobiral therapy	—

Secondary

Measure	Time frame
Efficacy at day 3-5, 14, 30 Safety	—

Countries

Japan

Contacts

Public ContactKazuo Tamura

Fukuoka University Depatment of Internal Medicine

ktamura@fukuoka-u.ac.jp092-801-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026