Antifungal Use in Oncohematological Neutropenic Patients

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00386802
First received: October 11, 2006
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ANTIVORIFUNGOL:Strategy of Antifungal Use in Oncohematological Neutropenic Patients. Use of Voriconazole as Early Treatment.

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Frequency of use of broad-spectrum antifungals in the episode of neutropenia. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and toxicity measure by: [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Frequency of Invader Fungal Infection. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Development of nephrotoxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Use of galactomannan in this clinical context [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time of administration of empirical antifungal therapy of broad-spectrum. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: August 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Antifungal drug. VORICONAZOL. (VFEND®)
    I.V charge dose 6 mg/kg/12h (2 doses) Maintenance iv treatment 4 mg/kg/12h during 6 days, followed by oral treatment (200 mg/12h)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00386802

Locations
Spain
Hospital General de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain
Hospital Clínic
Barcelona, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Spain
Hospital General Universitario Gregorio Marañón, Madrid
Madrid, Spain
Hospital Universitario Morales Meseguer, Murcia
Murcia, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Principal Investigator: de la Cámara Rafael, Dr Hospital Universitario de la Princesa, Madrid
  More Information

Additional Information:
Publications:

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00386802     History of Changes
Other Study ID Numbers: 2005-004973-55, ANTIVORIFUNGOL
Study First Received: October 11, 2006
Last Updated: September 17, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Neutropenia
Antifungals

Additional relevant MeSH terms:
Mycoses
Antifungal Agents
Clotrimazole
Miconazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014