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Antifungal Use in Oncohematological Neutropenic Patients

Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invader Fungal Infection

Intervention: Antifungal drug. VORICONAZOL. (VFEND®) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
de la Cámara Rafael, Dr, Principal Investigator, Affiliation: Hospital Universitario de la Princesa, Madrid


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Frequency of use of broad-spectrum antifungals in the episode of neutropenia.

Secondary outcome:

To determine the safety and toxicity measure by:

Frequency of Invader Fungal Infection.

Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study.


Development of nephrotoxicity

Use of galactomannan in this clinical context

Time of administration of empirical antifungal therapy of broad-spectrum.

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


Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult and pediatric patients (from 2 years old on) with diagnostic of hematologic

malignancies or solid tumour.

- Patients who will develop neutropenia (<500PN) post chemotherapy or post Bone Marrow

Transplantation (BMT) that according to the center, they can receive empirical antifungal treatment of broad-spectrum.

- Controlled patients with galactomannan in blood twice weekly.

- Empirical antibacterial therapy of broad-spectrum, as possible the Pethema protocol

that it is activated in this moment. Also it will be validated the monotherapy with carbapenemic or cephalosporin of fourth or third generation, or the biotherapy.

- Inclusion of patient since the start of his chemotherapy or therapy of preparation.

- If a bacterial infection is documented, it will be treated and controlled before to

begin the empirical antifungal treatment.

- Signed of informed consent.

- Negative pregnancy test in fertile patients

Exclusion Criteria:

- Use of antifungal prophylaxis with triazoles with activity against Aspergillus, or

use of others systematics antifungal by previous Invader Fungal Infection or other reasons.

- Use prophylactic of fluconazole to dose higher than 100 mg/day.

- Allergy to azoles

- To have a invader fungal infection at start of episode of neutropenia with fever.

- High effect in the unity of insulation of Candida strong to fluconazole that to

opinion of center it hasn´t appropriate to include in a protocol where it is considered the use of empirical fluconazole.

- Neutropenias made by aplastic anemia or other faults of bone similar.

- Inclusion previous in this study.

- The patients will be excluded if they have settled by Aspergillus, C. krusei or

C. gladiata in this episode of neutropenia, or in other and if they lack of the results of the cultures of vigilance in the present episode. If it presents positive result for any of those pathogens the empirical treatment will must be with a antifungal that it covers good (amphotericin, caspofungin or voriconazole) and not with fluconazole, then those patients will not follow this protocol.

- To receive drugs, which aren´t indicated in patients in treatment with voriconazole

and/or with fluconazole.

- The patients will not be excluded if they receive antibacterial prophylaxis oral with

quinolones, macrolides, etc., or stimulating factors G-CSF, GM-CSF or similar.

- Cause of exclusion will be the fault of fulfilment of inclusion criteria. Above all

the patients will be excluded if they:

- have fault of twice weekly monitoring with galactomannan.

- have a bacterial infection not very good treated and controlled before to can begin

the empirical antifungal infection (according to definition previous)

- have at final, a neutropenia of short stay that it has a risk important of Invader

Fungal Infection. This data naturally will not know in the moment of include at patient in the study. It defines as neutropenia of short stay if it last out less of 5 days.

Locations and Contacts

Hospital Clínic, Barcelona, Spain

Hospital Virgen de las Nieves, Granada, Spain

Hospital General Universitario Gregorio Marañón, Madrid, Madrid, Spain

Hospital Universitario de la Princesa, Madrid, Spain

Hospital Universitario Ramón y Cajal, Madrid, Madrid, Spain

Hospital Universitario Morales Meseguer, Murcia, Murcia, Spain

Hospital Clínico Universitario de Salamanca, Salamanca, Spain

Hospital Universitario Marqués de Valdecilla, Santander, Spain

Hospital Clínico Universitario de Valencia, Valencia, Spain

Hospital Universitario La Fe, Valencia, Spain

Hospital Clínico Lozano Blesa, Zaragoza, Spain

Hospital General de Jerez de la Frontera, Jerez de la Frontera, Cádiz, Spain

Hospital Son Llatzer, Palma de Mallorca, Mallorca, Spain

Additional Information

Spanish association of Haematology

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Starting date: August 2006
Last updated: September 17, 2009

Page last updated: August 23, 2015

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