A randomized controlled trial to compare empiric antifungal therapy and D-index-guided early therapy during neutropenia. (CEDMIC trial)

A randomized controlled trial to compare empiric antifungal therapy and D-index-guided early therapy during neutropenia. (CEDMIC trial) - RCT to compare empiric antifungal therapy and D-index-guided early therapy (CEDMIC trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010411

Enrollment

420

Registered

2013-05-01

Start date

2013-05-01

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

Hematological malignancies(acute leukemia, myelodysplastic syndrome, lymphoma, myeloma, and so on)

Interventions

D-index-guided early antifungal therapy Empiric antifungal therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with hematological malignancies who undergo chemotherapy or stem cell transplantation 2)Aged between 16 and 79 years 3)Expected duration of neutropenia at least 7 days 4)No grade III-IV renal or liver dysfunction 5)ECOG-PS 0-2 6)Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1)Previous history of invasive fungal infection 2)Receiving antifungal agents other than prophylactic administration 3)Suspected active infection 4)Planned to receive antifungal prophylaxis with polyenes or candins 5)Allergic reaction to candins 6)Pregnant or possibly pregnant 7)HIV positive 8)Not suitable for thie trial judged by attending physicians

Design outcomes

Primary

Measure	Time frame
Proven/Probable invasive fungal infection	—

Countries

Japan

Contacts

Public ContactYoshinobu Kanda

Japan Febrile Neutropenia Study Group Japan Febrile Neutropenia Study Group

ycanda-tky@umin.ac.jp092-801-2845

Outcome results

None listed

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