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

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

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Study Overview

• Status: Completed
• Conditions: Infections
• Intervention / Treatment: Procedure: Aspergillus PCR technique; Procedure: Aspergillus AGA technique

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario de A Coruña
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Vall D´Hebron
  • Girona, Spain, 17007
    • Hospital Josep Trueta
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Murcia, Spain, 30008
    • Hospital Morales Meseguer
  • Oviedo, Spain, 33006
    • Hospital Central de Asturias
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Lozano Blesa
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of hematological patients at high risk of invasive fungal infection. Like: Leukemia acute mieloblasticas, myelodysplastic syndrome, patients with intensive chemotherapy and allogeneic hematopoietic transplantation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High Risk Oncohematological Patients; Detection Aspergillus PCR technique and Aspergillus AGA technique	Procedure: Aspergillus PCR technique; Aspergillus DNA PCR technique; Procedure: Aspergillus AGA technique; Aspergillus AGA technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
• Investigators: Principal Investigator: Lourdes Vazquez, MD, University of Salamanca; Principal Investigator: Isabel Ruiz, Md, Hospital Vall D´Hebron; Principal Investigator: Rocio Parody, MD, Hospital Virgen del Rocío; Principal Investigator: Javier Lopez, MD, Hospital Ramon y Cajal; Principal Investigator: Montserrat Rovira, MD, Hospital Clinic of Barcelona; Principal Investigator: Montserrat Batlle, MD, Germans Trias i Pujol Hospital; Principal Investigator: Carlos Vallejo, MD, Hospital Central de Asturias; Principal Investigator: Rosario Varela, MD, Hospital de A Coruña; Principal Investigator: Inmaculada Heras, MD, Hospital Morales Meseguer; Principal Investigator: Joaquin Diaz, MD, Hospital Clinico San Carlos; Principal Investigator: Carlos Solano, MD, Hospital Clinico de Valencia; Principal Investigator: Maria Teresa Olave, MD, Hospital Lozano Blesa; Principal Investigator: David Gallardo, MD, H. Josep Trueta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: High risk aspergillosis infection patients
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Aspergillosis
• Other Study ID Numbers: GETH-PCRAGA