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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01742026
Other study ID # GETH-PCRAGA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2011
Est. completion date December 2012

Study information

Verified date March 2022
Source Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Aspergillus PCR technique
Aspergillus DNA PCR technique
Aspergillus AGA technique
Aspergillus AGA technique

Locations

Country Name City State
Spain Complejo Hospitalario de A Coruña A Coruña
Spain Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Vall d´Hebron Barcelona
Spain Hospital Josep Trueta Girona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Ramon y Cajal Madrid
Spain Hospital morales Meseguer Murcia
Spain Hospital Central de Asturias Oviedo
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Virgen del Rocio Sevilla
Spain Hospital Clinico de Valencia Valencia
Spain Hospital Clinico Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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