Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01128907|
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : February 24, 2014
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|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Observational Model:||Case Control|
|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 :||October 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Hematological neutropenic patients at high risk of Invasive Aspergillosis with persistent fever and an opportunist infection suspicion.
Patients without hematological illness and without Invasive Aspergillosis suspicion.
- Galactomannan antigen and Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage. [ Time Frame: 3 years ]Cross-sectional design.
- Utility of Galactomannan antigen and Real Time - PCR for Aspergillus DNA in BAL as a diagnostic method of IA. [ Time Frame: 3 years ]Cross-sectional design.
- Galactomannan Antigen and Real Time- PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility? [ Time Frame: 3 years ]cross-sectional design.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128907
|Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|