Invasives Aspergillosis in Acute Myeloid Leukemia (IA-AML)

The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Invasive Aspergillosis
• Intervention / Treatment: Other: Patients without antifungal prophylaxis; Drug: Patients with antifungal prophylaxis

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 Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults patients treated for acute myeloid leukemia by intensive chemotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients without antifungal prophylaxis; Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis.	Other: Patients without antifungal prophylaxis; Epidemiology data: clinical and biological informations collecting
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.	Other: Patients without antifungal prophylaxis; Epidemiology data: clinical and biological informations collecting; Drug: Patients with antifungal prophylaxis; Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of invasive aspergillosis in acute myeloid leukemia	Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency of antifungal prophylaxis by posaconazole	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	1 year
Impact of antifungal prophylaxis by posaconazole about construction/demolition periods	Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Gaelle Guillerm, MD, Department of Hematology, Brest Teaching Hospital; Principal Investigator: Lenaig Le Clech, MD, Department of Hematology, Brest Teaching Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Neoplasms by Histologic Type; Neoplasms; Bacterial Infections and Mycoses; Mycoses; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Aspergillosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: IA-AML

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO