Aspergillus PCR Early Detection in High Risk Oncohematological Patients

NCT ID: NCT01742026

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-12-31

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

Conditions

Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

High Risk Oncohematological Patients

Detection Aspergillus PCR technique and Aspergillus AGA technique

Aspergillus PCR technique

Intervention Type: PROCEDURE

Aspergillus DNA PCR technique

Aspergillus AGA technique

Intervention Type: PROCEDURE

Aspergillus AGA technique

Interventions

Aspergillus PCR technique

Aspergillus DNA PCR technique

Intervention Type: PROCEDURE

Aspergillus AGA technique

Aspergillus AGA technique

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lourdes Vazquez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Isabel Ruiz, Md

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d´Hebron

Rocio Parody, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Rocio

Javier Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Ramon y Cajal

Montserrat Rovira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Montserrat Batlle, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Carlos Vallejo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Central de Asturias

Rosario Varela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de A Coruña

Inmaculada Heras, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Morales Meseguer

Joaquin Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Carlos Solano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico de Valencia

Maria Teresa Olave, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Lozano Blesa

David Gallardo, MD

Role: PRINCIPAL_INVESTIGATOR

H. Josep Trueta

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Complejo Hospitalario de A Coruña

A Coruña, , Spain

Hospital Vall d´Hebron

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Josep Trueta

Girona, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital morales Meseguer

Murcia, , Spain

Hospital Central de Asturias

Oviedo, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Virgen del Rocio

Seville, , Spain

Hospital Clinico de Valencia

Valencia, , Spain

Hospital Clinico Lozano Blesa

Zaragoza, , Spain

Countries

Spain

References

Aguado JM, Vazquez L, Fernandez-Ruiz M, Villaescusa T, Ruiz-Camps I, Barba P, Silva JT, Batlle M, Solano C, Gallardo D, Heras I, Polo M, Varela R, Vallejo C, Olave T, Lopez-Jimenez J, Rovira M, Parody R, Cuenca-Estrella M; PCRAGA Study Group; Spanish Stem Cell Transplantation Group; Study Group of Medical Mycology of the Spanish Society of Clinical Microbiology and Infectious Diseases; Spanish Network for Research in Infectious Diseases. Serum galactomannan versus a combination of galactomannan and polymerase chain reaction-based Aspergillus DNA detection for early therapy of invasive aspergillosis in high-risk hematological patients: a randomized controlled trial. Clin Infect Dis. 2015 Feb 1;60(3):405-14. doi: 10.1093/cid/ciu833. Epub 2014 Oct 21.

Reference Type: DERIVED

PMID: 25336623 (View on PubMed)

Other Identifiers

GETH-PCRAGA

Identifier Type: -

Identifier Source: org_study_id