An observational study in Acute Myeloid Leukemia and Invasive Aspergillosis, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by University Hospital, Brest · Observational
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.
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.
201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.
This study's enrollment of 246 is above the median of 150 across 81 observational studies indexed under Aspergillosis.
Browse Aspergillosis studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
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Adults patients treated for acute myeloid leukemia by intensive chemotherapy
Exclusion Criteria:
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
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 · Drug: Patients with antifungal prophylaxis
Epidemiology data: clinical and biological informations collecting
Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.
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
Time frame: 1 year
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
Time frame: 1 year
Impact of antifungal prophylaxis by posaconazole about construction/demolition periods
Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest