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OpenTrials
Completed

NCT Number: NCT02900430

Invasives 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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Invasive Aspergillosis Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Patients without antifungal prophylaxis

Other

Epidemiology data: clinical and biological informations collecting

Patients with antifungal prophylaxis

Drug

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

Primary outcomes

  1. Incidence of invasive aspergillosis in acute myeloid leukemia

    Time frame: 1 year

    Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015

Secondary outcomes

  1. Efficiency of antifungal prophylaxis by posaconazole

    Time frame: 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

  2. Impact of antifungal prophylaxis by posaconazole about construction/demolition periods

    Time frame: 1 year

    Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

Acronym: IA-AML

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2016
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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