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

NCT00190463 | Terminated Phase 4

• 2 other identifiers: P020905AOR02028
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Hemopathy; Duration of Neutropenia Following Chemotherapy > 10 Days

Keywords

aspergillosis; antifungal therapy; empirical antifungal treatment

Outcome Measures

Primary Outcomes (1)

• Mortality at 60 days

Secondary Outcomes (3)

• Day with fever

• Fungal infections

• Costs

Interventions

Amphotericin B DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malignant Hemopathy
• Induction or consolidation phase of chemotherapy, with expected neutropenia (\< 500/mm3) during at least 10 days
• Hospitalisation during aplasia

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Chu Henri Mondor

Paris, Île-de-France Region, 94000, France

Location

Related Publications (1)

• 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. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.

  PMID: 11850858 BACKGROUND

MeSH Terms

Conditions

Aspergillosis

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Catherine CORDONNIER, Pr,MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2003
• Study Completion: July 1, 2006
• Last Updated: September 21, 2006

Record last verified: 2006-09

Locations

FR (1)