NCT00386802

Antifungal Use in Oncohematological Neutropenic Patients

ANTIVORIFUNGOL:Strategy of Antifungal Use in Oncohematological Neutropenic Patients. Use of Voriconazole as Early Treatment.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of neutropenia. Secondary purposes:To determine the safety and toxicity measure by: 1. Frequency of Invader Fungal Infection. 2. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. 3. Mortality 4. Development of nephrotoxicity 5. Use of galactomannan in this clinical context 6. Time of administration of empirical antifungal therapy of broad-spectrum.

Detailed description

Clinical trial with a pharmaceutical speciality in the conditions of authorized use

Conditions

• Invader Fungal Infection

Interventions

Type	Name	Description
DRUG	Antifungal drug. VORICONAZOL. (VFEND®)	I.V charge dose 6 mg/kg/12h (2 doses) Maintenance iv treatment 4 mg/kg/12h during 6 days, followed by oral treatment (200 mg/12h)

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2006-10-12
• Last updated: 2009-09-18

Locations

13 sites across 1 country: Spain