Status:
TERMINATED
Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Malignant Hemopathy
Duration of Neutropenia Following Chemotherapy > 10 Days
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to...
Detailed Description
Patients are eligible if they have an hematologic malignancy, and receive chemotherapy with an expected neutropenic phase of \> 10 days. Patients are randomized according to a 1:1 ratio to receive eit...
Eligibility Criteria
Inclusion
- Malignant Hemopathy
- Induction or consolidation phase of chemotherapy, with expected neutropenia (\< 500/mm3) during at least 10 days
- Hospitalisation during aplasia
Exclusion
- allogeneic haematopoietic stem cell transplants
- Previous fungal infection according to EORTC-MSG criteria
- Active fungal infection according to EORTC-MSG criteria
- Previous anaphylactic intolerance to polyenes
- known aspergillosis infection
- Sepsis
- Pneumopathy
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00190463
Start Date
April 1 2003
End Date
July 1 2006
Last Update
September 21 2006
Active Locations (1)
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1
Chu Henri Mondor
Paris, Île-de-France Region, France, 94000