Overview

This trial is active, not recruiting.

Condition infections
Treatments aspergillus pcr technique, aspergillus aga technique
Phase phase 4
Sponsor Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Start date February 2011
End date December 2012
Trial size 225 participants
Trial identifier NCT01742026, GETH-PCRAGA

Summary

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Detection Aspergillus PCR technique and Aspergillus AGA technique
aspergillus pcr technique
Aspergillus DNA PCR technique
aspergillus aga technique
Aspergillus AGA technique

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
Principal investigator Lourdes Vazquez, MD
Description ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.