Aspergillus PCR Early Detection in High Risk Oncohematological Patients

Infections Clinical Trial

— PCRAGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742026
• Other study ID #: GETH-PCRAGA
• Status: Completed
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2022
• Source: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Infections

Intervention

Procedure:
• Aspergillus PCR technique
Aspergillus DNA PCR technique
• Aspergillus AGA technique
Aspergillus AGA technique

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de A Coruña	A Coruña
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Vall d´Hebron	Barcelona
Spain	Hospital Josep Trueta	Girona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital morales Meseguer	Murcia
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospital Clinico de Valencia	Valencia
Spain	Hospital Clinico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum	To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.	18-20 months