Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Amphotericin B; Antifungal Agents; Liposomal amphotericin B; Miconazole

Criteria

Inclusion Criteria:

• Malignant Hemopathy

• Induction or consolidation phase of chemotherapy, with expected neutropenia (< 500/mm3) during at least 10 days

• Hospitalisation during aplasia

Exclusion Criteria:

• 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