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Invasives Aspergillosis in Acute Myeloid Leukemia

The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02900430
Acronym
IA-AML
Enrollment
246
Registered
2016-09-14
Start date
2009-01-31
Completion date
2015-12-31
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Invasive Aspergillosis

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.

Interventions

OTHERPatients without antifungal prophylaxis

Epidemiology data: clinical and biological informations collecting

DRUGPatients with antifungal prophylaxis

Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of invasive aspergillosis in acute myeloid leukemia1 yearEvaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015

Secondary

MeasureTime frameDescription
Efficiency of antifungal prophylaxis by posaconazole1 yearComparison 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 periods1 yearComparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026