Aspergillus PCR Early Detection in High Risk Oncohematological Patients

NCT01742026 | Completed

• 1 other identifier: GETH-PCRAGA
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 13

Brief Summary

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Conditions

Infections

Keywords

High risk aspergillosis infection patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

High Risk Oncohematological Patients

Detection Aspergillus PCR technique and Aspergillus AGA technique

Procedure: Aspergillus PCR technique; Procedure: Aspergillus AGA technique

Interventions

Aspergillus PCR technique PROCEDURE

Aspergillus DNA PCR technique

High Risk Oncohematological Patients

Aspergillus AGA technique PROCEDURE

Aspergillus AGA technique

High Risk Oncohematological Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Grupo Espanol de trasplantes hematopoyeticos y terapia celular: lead

Study Sites (13)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Complejo Hospitalario de A Coruña

A Coruña, 15006, Spain

Location

Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Josep Trueta

Girona, 17007, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital morales Meseguer

Murcia, 30008, Spain

Location

Hospital Central de Asturias

Oviedo, 33006, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico de Valencia

Valencia, 46010, Spain

Location

Hospital Clinico Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 25336623 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Lourdes Vazquez, MD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Isabel Ruiz, Md

  Hospital Vall d´Hebron

  PRINCIPAL INVESTIGATOR

• Rocio Parody, MD

  Hospital Virgen del Rocio

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: December 5, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

ES (13)