Invasives Aspergillosis in Acute Myeloid Leukemia

Completed

• Conditions: Acute Myeloid Leukemia; Invasive Aspergillosis
• Interventions: Other: Patients without antifungal prophylaxis; Drug: Patients with antifungal prophylaxis

• Registration Number: NCT02900430
• Lead Sponsor: University Hospital, Brest

Brief Summary

Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.

Detailed Description

Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-09
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-09
• Last Update Submitted: 2016-09-09
• Study First Posted: 2016-09-14
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• > 18 years
• acute myeloid leukemia
• intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation)

Exclusion Criteria

• < 18 years
• pregnancy
• no intensive chemotherapy (palliative treatment, azacytidine...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with antifungal prophylaxis	Patients without antifungal prophylaxis	Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole.
Patients with antifungal prophylaxis	Patients with antifungal prophylaxis	Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole.
Patients without antifungal prophylaxis	Patients without antifungal prophylaxis	Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis.

Primary Outcome Measures

Name	Time	Method
Incidence of invasive aspergillosis in acute myeloid leukemia	1 year	Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015

Secondary Outcome Measures

Name	Time	Method
Efficiency of antifungal prophylaxis by posaconazole	1 year	Comparison of two periods: 2009-2011 where patients had not antifungal prophylaxis and 2012-2015 where patients had antifungal prophylaxis by posaconazole during induction and salvage chemotherapy
Impact of antifungal prophylaxis by posaconazole about construction/demolition periods	1 year	Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France