Aspergillus PCR Early Detection in High Risk Oncohematological Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier:
NCT01742026
First received: October 30, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION


Condition Intervention Phase
Infections
Procedure: Aspergillus PCR technique
Procedure: Aspergillus AGA technique
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS

Resource links provided by NLM:


Further study details as provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:

Primary Outcome Measures:
  • Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum [ Time Frame: 18-20 months ] [ Designated as safety issue: No ]
    To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.


Enrollment: 225
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742026

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Complejo Hospitalario de A Coruña
A Coruña, Spain, 15006
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Josep Trueta
Girona, Spain, 17007
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital morales Meseguer
Murcia, Spain, 30008
Hospital Central de Asturias
Oviedo, Spain, 33006
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Hospital Clinico de Valencia
Valencia, Spain, 46010
Hospital Clinico Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Investigators
Principal Investigator: Lourdes Vazquez, MD Hospital Universitario de 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 de Barcelona
Principal Investigator: Montserrat Batlle, MD HOSPITAL GERMANS TRIAS I PUJOL
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
  More Information

No publications provided

Responsible Party: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier: NCT01742026     History of Changes
Other Study ID Numbers: GETH-PCRAGA
Study First Received: October 30, 2012
Last Updated: December 3, 2012
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ethics Committee

Keywords provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:
High risk aspergillosis infection patients

Additional relevant MeSH terms:
Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014