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Trial record 18 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

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

Tracking Information
First Submitted Date September 2, 2016
First Posted Date September 14, 2016
Last Update Posted Date September 14, 2016
Study Start Date January 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2016)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 9, 2016)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Invasives Aspergillosis in Acute Myeloid Leukemia
Official Title The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia
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.
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults patients treated for acute myeloid leukemia by intensive chemotherapy
Condition
  • Acute Myeloid Leukemia
  • Invasive Aspergillosis
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.
Study Groups/Cohorts
  • Patients without antifungal prophylaxis
    Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis.
    Intervention: Other: Patients without antifungal prophylaxis
  • 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.
    Interventions:
    • Other: Patients without antifungal prophylaxis
    • Drug: Patients with antifungal prophylaxis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 9, 2016)
246
Original Actual Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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...)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02900430
Other Study ID Numbers IA-AML
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Principal Investigator: Gaelle Guillerm, MD Department of Hematology, Brest Teaching Hospital
Principal Investigator: Lenaig Le Clech, MD Department of Hematology, Brest Teaching Hospital
PRS Account University Hospital, Brest
Verification Date September 2016