Antifungal Use in Oncohematological Neutropenic Patients

September 17, 2009 updated by: PETHEMA Foundation

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

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

Secondary purposes: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.
Mortality
Development of nephrotoxicity
Use of galactomannan in this clinical context
Time of administration of empirical antifungal therapy of broad-spectrum.

Study Overview

Status

Completed

Conditions

Invader Fungal Infection

Intervention / Treatment

Drug: Antifungal drug. VORICONAZOL. (VFEND®)

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain
    - Hospital Clinic
  - Granada, Spain
    - Hospital Virgen de las Nieves
  - Madrid, Spain
    - Hospital Universitario de La Princesa
  - Madrid, Spain
    - HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID
  - Madrid, Spain
    - Hospital Universitario Ramón y Cajal, Madrid
  - Murcia, Spain
    - Hospital Universitario Morales Meseguer, Murcia
  - Salamanca, Spain
    - Hospital Clinico Universitario de Salamanca
  - Santander, Spain
    - Hospital Universitario Marqués de Valdecilla
  - Valencia, Spain
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spain
    - Hospital Universitario La Fe
  - Zaragoza, Spain
    - Hospital Clinico Lozano Blesa
- Cádiz
  - Jerez de la Frontera, Cádiz, Spain
    - Hospital general de Jerez de la Frontera
- Mallorca
  - Palma de Mallorca, Mallorca, Spain
    - Hospital Son Llatzer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of use of broad-spectrum antifungals in the episode of neutropenia. Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality Time Frame: 2 years	2 years
To determine the safety and toxicity measure by: Time Frame: 1 year	1 year
Frequency of Invader Fungal Infection. Time Frame: 2 years	2 years
Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. Time Frame: 2 years	2 years
Development of nephrotoxicity Time Frame: 2 years	2 years
Use of galactomannan in this clinical context Time Frame: 2 years	2 years
Time of administration of empirical antifungal therapy of broad-spectrum. Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

Principal Investigator: de la Cámara Rafael, Dr, Hospital Universitario de la Princesa, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Spanish association of Haematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria