Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Invasives Aspergillosis in Acute Myeloid Leukemia (IA-AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900430
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Invasive Aspergillosis 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 246 participants
Observational Model: Cohort
Official Title: The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia
Study Start Date : January 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults patients treated for acute myeloid leukemia by intensive chemotherapy
Criteria

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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900430


Locations
Layout table for location information
France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
Layout table for investigator information
Principal Investigator: Gaelle Guillerm, MD Department of Hematology, Brest Teaching Hospital
Principal Investigator: Lenaig Le Clech, MD Department of Hematology, Brest Teaching Hospital

Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02900430     History of Changes
Other Study ID Numbers: IA-AML
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspergillosis
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Mycoses
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors