Aspergillus PCR Early Detection in High Risk Oncohematological Patients

Completed

• Conditions: Infections
• Interventions: Procedure: Aspergillus PCR technique; Procedure: Aspergillus AGA technique

• Registration Number: NCT01742026
• Lead Sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Brief Summary

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Detailed Description

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

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-10-30
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Risk Oncohematological Patients	Aspergillus AGA technique	Detection Aspergillus PCR technique and Aspergillus AGA technique
High Risk Oncohematological Patients	Aspergillus PCR technique	Detection Aspergillus PCR technique and Aspergillus AGA technique

Primary Outcome Measures

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

Trial Locations

Locations (13)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Vall d´Hebron; 🇪🇸 Barcelona, Spain

Complejo Hospitalario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Josep Trueta; 🇪🇸 Girona, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Clinico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Clinico de Valencia; 🇪🇸 Valencia, Spain