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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01128907
First received: March 19, 2010
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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
Invasive Aspergillosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Galactomannan antigen and Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cross-sectional design.


Secondary Outcome Measures:
  • Utility of Galactomannan antigen and Real Time - PCR for Aspergillus DNA in BAL as a diagnostic method of IA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cross-sectional design.

  • Galactomannan Antigen and Real Time- PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility? [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    cross-sectional design.


Enrollment: 200
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. hematological neutropenic patients at high risk of IA in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion.
  2. patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason.
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01128907

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01128907     History of Changes
Other Study ID Numbers: PR03/03/2007
Study First Received: March 19, 2010
Last Updated: February 21, 2014
Health Authority: Spain: Ethics Committee

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
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014