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Aspergillus PCR Early Detection in High Risk Oncohematological Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01742026
Acronym
PCRAGA
Enrollment
225
Registered
2012-12-05
Start date
2011-02-28
Completion date
2012-12-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections

Keywords

High risk aspergillosis infection patients

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

Interventions

PROCEDUREAspergillus PCR technique

Aspergillus DNA PCR technique

PROCEDUREAspergillus AGA technique

Aspergillus AGA technique

Sponsors

Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum18-20 monthsTo value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026