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

Tracking Information
First Submitted Date ICMJE	September 15, 2005
First Posted Date ICMJE	September 19, 2005
Last Update Posted Date	September 21, 2006
Study Start Date ICMJE	April 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 16, 2005)	Mortality at 60 days
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00190463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 16, 2005)	Day with fever; Fungal infections; Costs
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia
Official Title ICMJE	The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"
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.
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 ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Malignant Hemopathy; Duration of Neutropenia Following Chemotherapy > 10 Days
Intervention ICMJE	Drug: Amphotericin B
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: September 16, 2005)	300
Original Enrollment ICMJE	Same as current
Study Completion Date	July 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00190463
Other Study ID Numbers ICMJE	P020905; AOR02028
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Assistance Publique - Hôpitaux de Paris
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Catherine CORDONNIER, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account	Assistance Publique - Hôpitaux de Paris
Verification Date	September 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP