Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia
Status:
Terminated
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
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 early diagnose, and are life-threatening. Historical trials have shown a small
benefit of survival when this strategy is used. According to the drug usde for this strategy,
safety and costs may be concerns. However, since this routine practice has been implemented
in hematology, new non-invasive biological diagnostic methods are available to early diagnose
fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study
is to show that limiting the administration of antifungals in this setting to patients with
clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces
the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of
patients treated with chemotherapy for hematologic malignancies.
Phase:
Phase 4
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Amphotericin B Antifungal Agents Liposomal amphotericin B Miconazole