Clinical trial NCT00386802: Antifungal Use in Oncohematological Neutropenic Patients
Official title: ANTIVORIFUNGOL:Strategy of Antifungal Use in Oncohematological Neutropenic Patients. Use of Voriconazole as Early Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Invader Fungal Infection
Keywords: Neutropenia
Antifungals
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2006-10-12
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of use of broad-spectrum antifungals in the episode of neutropenia.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the safety and toxicity measure by:
timeFrame: 1 year
measure: Frequency of Invader Fungal Infection.
timeFrame: 2 years
measure: Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study.
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: Development of nephrotoxicity
timeFrame: 2 years
measure: Use of galactomannan in this clinical context
timeFrame: 2 years
measure: Time of administration of empirical antifungal therapy of broad-spectrum.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital General de Jerez de la Frontera
state: Cádiz
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Mallorca
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal, Madrid
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer, Murcia
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Hospital Universitario de la Princesa, Madrid
name: de la Cámara Rafael, Dr
role: PRINCIPAL_INVESTIGATOR
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