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Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia
This study has been terminated.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | September 15, 2005 | |||
| Last Updated Date | September 20, 2006 | |||
| Start Date ICMJE | April 2003 | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE |
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 |
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| 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 |
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| Condition ICMJE |
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| 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. | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 300 | |||
| Estimated Completion Date | July 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| 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 |
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| PRS Account | Assistance Publique - Hôpitaux de Paris | |||
| Verification Date | September 2006 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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