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Aspergillus PCR Early Detection in High Risk Oncohematological Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01742026
Recruitment Status : Unknown
Verified December 2012 by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Tracking Information
First Submitted Date October 30, 2012
First Posted Date December 5, 2012
Last Update Posted Date December 5, 2012
Study Start Date February 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 3, 2012)
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 ]
To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aspergillus PCR Early Detection in High Risk Oncohematological Patients
Official Title ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Infections
Intervention
  • Procedure: Aspergillus PCR technique
    Aspergillus DNA PCR technique
  • Procedure: Aspergillus AGA technique
    Aspergillus AGA technique
Study Groups/Cohorts High Risk Oncohematological Patients
Detection Aspergillus PCR technique and Aspergillus AGA technique
Interventions:
  • Procedure: Aspergillus PCR technique
  • Procedure: Aspergillus AGA technique
Publications * Aguado JM, Vázquez L, Fernández-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, López-Jiménez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: December 3, 2012)
225
Original Actual Enrollment Same as current
Estimated Study Completion Date December 2012
Primary Completion Date Not Provided
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.

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01742026
Other Study ID Numbers GETH-PCRAGA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Study Sponsor Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Collaborators Not Provided
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 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
PRS Account Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Verification Date December 2012