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Antifungal Use in Oncohematological Neutropenic Patients

NCT00386802 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2009-09-18

No results posted yet for this study

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.

Conditions

  • Invader Fungal Infection

Interventions

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)

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • de la Cámara Rafael, Dr · Hospital Universitario de la Princesa, Madrid

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00386802 on ClinicalTrials.gov