Antifungal Use in Oncohematological Neutropenic Patients

Phase 4

Completed

• Conditions: Invader Fungal Infection

• Registration Number: NCT00386802
• Lead Sponsor: PETHEMA Foundation

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

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-12
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of use of broad-spectrum antifungals in the episode of neutropenia.	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Hospital Universitario Morales Meseguer, Murcia; 🇪🇸 Murcia, Spain

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital General Universitario Gregorio Marañón, Madrid; 🇪🇸 Madrid, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Mallorca, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario Ramón y Cajal, Madrid; 🇪🇸 Madrid, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Hospital General de Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Cádiz, Spain