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Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia

This study has been terminated.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190463
First received: September 15, 2005
Last updated: September 20, 2006
Last verified: September 2006
History of Changes
  Purpose

Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Historical trials have shown a small benefit of survival when this strategy is used. According to the drug usde for this strategy, safety and costs may be concerns. However, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.


Condition Intervention Phase
Malignant Hemopathy
Duration of Neutropenia Following Chemotherapy > 10 Days
 Drug: Amphotericin B
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Mortality at 60 days

Secondary Outcome Measures:
  • Day with fever
  • Fungal infections
  • Costs

Estimated Enrollment: 300
Study Start Date: April 2003
Estimated Study Completion Date: July 2006
Detailed Description:

Patients are eligible if they have an hematologic malignancy, and receive chemotherapy with an expected neutropenic phase of > 10 days. Patients are randomized according to a 1:1 ratio to receive either the usual empirical strategy (antifungals are introduced if they have persistent fever after 4 days of broad-spectrum antibacterials) or the pre-empirical strategy (administration of antifungals is limited to patients with pneumonia, septic shock, sinusitis, grade 3 mucositis, aspergillus colonization, liver or splenic abscesses, or positive galactomannan antigenemia). The antifungals administered are deoxycholate amphotericin B or liposome amphotericin B, according to the creatinin clearance. This strategy is applied during the first 14 days of persistent fever, then the therapy is left at the discretion of the investigator. The primary endpoint is survival at neutrophil recovery, or, in case of persistent neutropenia, at day 60 at the latest. Secondary objectives are the incidence of invasive fungal infections (IFI), IFI-free survival, number of febrile days, and renal function at study completion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malignant Hemopathy
  • Induction or consolidation phase of chemotherapy, with expected neutropenia (< 500/mm3) during at least 10 days
  • Hospitalisation during aplasia

Exclusion Criteria:

  • allogeneic haematopoietic stem cell transplants
  • Previous fungal infection according to EORTC-MSG criteria
  • Active fungal infection according to EORTC-MSG criteria
  • Previous anaphylactic intolerance to polyenes
  • known aspergillosis infection
  • Sepsis
  • Pneumopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190463

Locations
France
Chu Henri Mondor
Paris, Ile de France, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Catherine CORDONNIER, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00190463     History of Changes
Other Study ID Numbers: P020905, AOR02028
Study First Received: September 15, 2005
Last Updated: September 20, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
aspergillosis
antifungal therapy
empirical antifungal treatment

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Clotrimazole
Miconazole
Amebicides
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013