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Antifungal Use in Oncohematological Neutropenic Patients

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ClinicalTrials.gov Identifier: NCT00386802
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
PETHEMA Foundation

Study Description
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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.

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

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Arms and Interventions
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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)

Outcome Measures
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Primary Outcome Measures :
  1. Frequency of use of broad-spectrum antifungals in the episode of neutropenia. [ Time Frame: 2 years ]

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

Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386802


Locations
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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 General Universitario Gregorio Marañón, Madrid
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal, 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
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Principal Investigator: de la Cámara Rafael, Dr Hospital Universitario de la Princesa, Madrid
More Information
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Additional Information:

Publications:

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Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00386802    
Other Study ID Numbers: 2005-004973-55
ANTIVORIFUNGOL
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009
Keywords provided by PETHEMA Foundation:
Neutropenia
Antifungals
Additional relevant MeSH terms:
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Mycoses
Antifungal Agents
Clotrimazole
Miconazole
Anti-Infective Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors