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Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT01128907
Collaborator
(none)
200
Enrollment
1
Location
74
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are the most affected group. IA has a very high morbimortality due to its rapid progression and because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an early stage: detection of Galactomannan antigen of Aspergillus species and real - time polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is mainly located in lungs, so our hypothesis is that in patients where the investigators suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection could be useful for diagnosis.

Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility.

Methods: Prospective study. The investigators will include 200 patients. 100 of them will be hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be patients without risk or no suspicion at all of IA. The investigators will perform a BAL in all patients. And blood detection of Galactomannan Antigen in hematological patients. The investigators will perform a standard microbiological culture of BAL and Galactomannan Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.

Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in BAL with more specificity and making earlier diagnosis than in blood. The investigators also expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Galactomannan Antigen and Real Time - PCR for Aspergillus DNA Detection in Bronchoalveolar Lavage. Application in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients
    Study Start Date :
    Oct 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Hematological neutropenic patients at high risk of Invasive Aspergillosis with persistent fever and an opportunist infection suspicion.
    2

    Patients without hematological illness and without Invasive Aspergillosis suspicion.

    Outcome Measures

    Primary Outcome Measures

    1. Galactomannan antigen and Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage. [3 years]

      Cross-sectional design.

    Secondary Outcome Measures

    1. Utility of Galactomannan antigen and Real Time - PCR for Aspergillus DNA in BAL as a diagnostic method of IA. [3 years]

      Cross-sectional design.

    2. Galactomannan Antigen and Real Time- PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility? [3 years]

      cross-sectional design.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 100 BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion.

    • 100 BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason.

    Exclusion Criteria:

    • Patients without fulfilling inclusion criteria.

    • Patients with some contraindication to perform a bronchoscopy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT01128907
    Other Study ID Numbers:
    • PR03/03/2007
    First Posted:
    May 24, 2010
    Last Update Posted:
    Feb 24, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Invasive Aspergillosis in neutropenic patients
    Additional relevant MeSH terms:
    Aspergillosis

    Study Results

    No Results Posted as of Feb 24, 2014