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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

September 15, 2005
September 20, 2006
April 2003
Not Provided
Mortality at 60 days
Same as current
Complete list of historical versions of study NCT00190463 on ClinicalTrials.gov Archive Site
  • Day with fever
  • Fungal infections
  • Costs
Same as current
Not Provided
Not Provided
 
Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Hemopathy
  • Duration of Neutropenia Following Chemotherapy > 10 Days
Drug: Amphotericin B
Not Provided
Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. Epub 2002 Feb 13. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
July 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190463
P020905, AOR02028
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Catherine CORDONNIER, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP