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Completed

NCT Number: NCT01742026

Aspergillus PCR Early Detection in High Risk Oncohematological Patients

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspergillus PCR technique

Procedure

Aspergillus DNA PCR technique

Aspergillus AGA technique

Procedure

Aspergillus AGA technique

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

    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.

Sponsors and collaborators

Lead sponsor

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Other

Registry information

Official study title

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

Acronym: PCRAGA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2012
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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