Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190463
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 21, 2006
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Hemopathy Duration of Neutropenia Following Chemotherapy > 10 Days Drug: Amphotericin B Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"
Study Start Date : April 2003
Study Completion Date : July 2006

Primary Outcome Measures :
  1. Mortality at 60 days

Secondary Outcome Measures :
  1. Day with fever
  2. Fungal infections
  3. Costs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00190463

Layout table for location information
Chu Henri Mondor
Paris, Ile de France, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for investigator information
Principal Investigator: Catherine CORDONNIER, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris

Layout table for additonal information Identifier: NCT00190463     History of Changes
Other Study ID Numbers: P020905
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 21, 2006
Last Verified: September 2006
Keywords provided by Assistance Publique - Hôpitaux de Paris:
antifungal therapy
empirical antifungal treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukocyte Disorders
Hematologic Diseases
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
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