Diagnosis of Invasive Pulmonary Aspergillosis, Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid (DipA2)

April 13, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf

Diagnosis of Invasive Pulmonary Aspergillosis (IPA) - Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid in Patients With and Without COVID-19

The aim of this research project is to compare the results of Aspergillus specific test methods Aspergillus Galactomannan Enzyme Immunoassay (GM-EIA), Aspergillus polymerase chain reaction (PCR), Aspergillus Galactomannan Lateral Flow Assay (LFA) from different respiratory tract secretions. The bronchoalveolar lavage (BAL) fluid and bronchial secretions (NBL) are compared in the same examination for each patient.

Study Overview

Status

Not yet recruiting

Detailed Description

Invasive pulmonary Infection with Aspergillus species has emerged as one of the most common causes of infectious death in critically ill patients (38%-79%). The incidence of invasive pulmonary Aspergillosis (IPA) in intensive care units is still not sufficiently clear and ranges between 0.3 % and 19 %. In the last two decades, IPA has been documented as an emerging disease in ICU patients without classic risk factors. The establishment of new therapeutic options in oncology with small-molecule kinase inhibitors (SMKI) and CAR (chimeric antigen receptor) T cell therapy have also led to an increase in IPA. Furthermore, during the influenza epidemics since 2009 and during the SARS-CoV-2 pandemic, IPA was observed in COVID-19 patients without classic risk factors. The cultural detection of molds can take between several days and up to 2 weeks, as this is a slow growing fungus. An Aspergillus Galactomannan EIA (enzyme immunoassay), an Aspergillus PCR (polymerase chain reaction) examination of the respiratory tract material is already available after 4-24 hours. A test using Aspergillus Galactomannan LFA (lateral flow assay) or LFD (lateral flow device) even furthers reduces this interval to 45 minutes. These tests allow the attending physician to initiate a much faster antimycotic treatment. Up to now, the samples for these examinations have been routinely obtained from bronchoscopically obtained bronchoalveolar lavage fluids. In this bronchoalveolar lavage (BAL), body-warm saline solution (NaCl) is instilled into segmental ostia of the lung and immediately re-aspirated . However, there are first indications that examinations from bronchial secretions using deep suction without bronchoscopy achieve similar results to the examination of the BAL. The bronchoscopic diagnosis in COVID-19 patients is probably associated with an increased risk of infection for the examiner due to the aerosol formation during this examination. Two studies from the first wave of the SARS-CoV-2 pandemic have therefore used secretions from the bronchial system = non-bronchoscopic lavage (NBL) to diagnose IPA. This method appears to be reasonable save, appropriate and less risky, but has never been scientifically validated for aspergillus infections. It is not yet clear whether the Aspergillus Galactomannan EIA, the Aspergillus PCR test and the Aspergillus LFA test provide comparable or transmissible results in both lung compartments. A direct comparison of the test results of the bronchoalveolar lavage (BAL) and the bronchial secretion (NBL) have not been described in the literature.

Study Design:

Monocentric prospective exploratory (and in the course confirmatory) cohort study.

  1. st pilot phase: Pilot study to test the feasibility and to gain information for the case number calculation of a subsequent larger prospective study.
  2. nd study phase: The statistically calculated number of patients who undergo a bronchoscopy during their stay at the UKE and who are urgently suspected of having IPA or who are confirmed to have IPA will be examined for bronchial secretions (NBL) and BAL fluids.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dominic Wichman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

4) Suspicion of invasive pulmonary aspergillosis:

(a) Clinical:

  • Neutropenia
  • Hematooncological disease
  • Allogeneic stem cell transplantation
  • Organ transplantation
  • SARS-CoV-2
  • Influenza

    b) Radiological:

  • Aspergillus typical findings on computed tomography.

    c) Microbiological:

  • Aspergillus positive findings from respiratory tract secretions (culture, galactomannan, PCR) or d) Confirmed invasive pulmonary aspergillosis.

Description

Inclusion Criteria:

  1. Age: at least 18 years
  2. Consent to prospective data collection.
  3. Clinical need for bronchoscopic examination.

Exclusion Criteria:

Refusal of consent to study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equivalence of quantitative results of Aspergillus galactomannan EIA examination from bronchial secretions (NBL) and BAL in one patient.
Time Frame: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
The Aspergillus antigen findings (galactomannan-EIA) quantitative show now deviation
The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of matched results (within a study participant) of Aspergillus PCR examination from BAL and NBL.
Time Frame: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
One patients results are same, positive or negative in both lung compartments (BAL and NBL).
The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
Number of matched results (within a study participant) of Aspergillus galactomannan LFA examination from BAL and NBL.
Time Frame: The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).
One patients results are same, positive or negative in both lung compartments (BAL and NBL).
The observation period for each individual patient begins with bronchoscopic examination (day 0) and ends after 90 days (day 90).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria Schroeder, MD, University Medical Center Hamburg-Eppendorf, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Pulmonary Aspergillosis

Subscribe