Antifungal Use in Oncohematological Neutropenic Patients

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00386802

Collaborator

(none)

115

Enrollment

Locations

Duration (Months)

8.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Invader Fungal Infection	Drug: Antifungal drug. VORICONAZOL. (VFEND®)	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

115 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

Frequency of use of broad-spectrum antifungals in the episode of neutropenia. [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital General de Jerez de la Frontera	Jerez de la Frontera	Cádiz	Spain
2	Hospital Son Llatzer	Palma de Mallorca	Mallorca	Spain
3	Hospital Clínic	Barcelona		Spain
4	Hospital Virgen de las Nieves	Granada		Spain
5	Hospital General Universitario Gregorio Marañón, Madrid	Madrid		Spain
6	Hospital Universitario de la Princesa	Madrid		Spain
7	Hospital Universitario Ramón y Cajal, Madrid	Madrid		Spain
8	Hospital Universitario Morales Meseguer, Murcia	Murcia		Spain
9	Hospital Clínico Universitario de Salamanca	Salamanca		Spain
10	Hospital Universitario Marqués de Valdecilla	Santander		Spain
11	Hospital Clínico Universitario de Valencia	Valencia		Spain
12	Hospital Universitario La Fe	Valencia		Spain
13	Hospital Clínico Lozano Blesa	Zaragoza		Spain