Aspergillus PCR Early Detection in High Risk Oncohematological Patients (PCRAGA)

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Status: Completed

Conditions: Infections

Treatments: Procedure: Aspergillus PCR technique; Procedure: Aspergillus AGA technique

Study type: Observational

Funder types: Other

Identifiers

NCT01742026

GETH-PCRAGA

Details and patient eligibility

About

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Full description

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

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

225 participants in 1 patient group

High Risk Oncohematological Patients

Description:

Detection Aspergillus PCR technique and Aspergillus AGA technique

Treatment:

Procedure: Aspergillus PCR technique

Procedure: Aspergillus AGA technique