Clinical trial NCT01742026: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections
Keywords: High risk aspergillosis infection patients
Lead sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

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
timeFrame: 18-20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: A Coruña
country: Spain
facility: Complejo Hospitalario de A Coruña
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: Hospital morales Meseguer
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
Study officials:
affiliation: University of Salamanca
name: Lourdes Vazquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d´Hebron
name: Isabel Ruiz, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Rocio
name: Rocio Parody, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Ramon y Cajal
name: Javier Lopez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Montserrat Rovira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Montserrat Batlle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Central de Asturias
name: Carlos Vallejo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de A Coruña
name: Rosario Varela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Morales Meseguer
name: Inmaculada Heras, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico San Carlos
name: Joaquin Diaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico de Valencia
name: Carlos Solano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Lozano Blesa
name: Maria Teresa Olave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Josep Trueta
name: David Gallardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aguado JM, Vazquez L, Fernandez-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, Lopez-Jimenez 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.