Status:
COMPLETED
Antifungal Use in Oncohematological Neutropenic Patients
Lead Sponsor:
PETHEMA Foundation
Conditions:
Invader Fungal Infection
Eligibility:
All Genders
2+ years
Phase:
PHASE4
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 Infe...
Detailed Description
Clinical trial with a pharmaceutical speciality in the conditions of authorized use
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00386802
Start Date
August 1 2006
End Date
January 1 2009
Last Update
September 18 2009
Active Locations (13)
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1
Hospital Clínic
Barcelona, Barcelona, Spain
2
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
3
Hospital General de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
4
Hospital Virgen de las Nieves
Granada, Granada, Spain