Aspergillus PCR Early Detection in High Risk Oncohematological Patients

Study Overview
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Brief Summary
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ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Detailed Description
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ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS

Official Title
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ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS

Conditions
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Infections

Intervention / Treatment
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* Procedure: Aspergillus PCR technique
* Procedure: Aspergillus AGA technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signature of informed consent to participate in the study. Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease. The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section. Exclusion Criteria: Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation). Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively. Background of IFI proven / probable prior Probable IFI / tested at the time of inclusion in the study. Exclusion will cause a lack of compliance with the inclusion criteria. Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to include the patient in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Risk Oncohematological Patients<br>Detection Aspergillus PCR technique and Aspergillus AGA technique | Procedure: Aspergillus PCR technique<br>* Aspergillus DNA PCR technique<br>Procedure: Aspergillus AGA technique<br>* Aspergillus AGA technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum | To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together. | 18-20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High risk aspergillosis infection patients