Invasives Aspergillosis in Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— IA-AML  

Official title:

The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900430
• Other study ID #: IA-AML
• Status: Completed
• Phase: N/A
• First received: September 2, 2016
• Last updated: September 9, 2016
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Aspergillosis
• Invasive Aspergillosis
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No