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

September 20, 2006 updated by: Assistance Publique - Hôpitaux de Paris

The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 94000
        • CHU Henri Mondor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality at 60 days

Secondary Outcome Measures

Outcome Measure
Costs
Day with fever
Fungal infections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Catherine CORDONNIER, Pr,MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 21, 2006

Last Update Submitted That Met QC Criteria

September 20, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P020905
  • AOR02028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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