PCR for Aspergillus Fumigatus in Blood and Bronchoalveolar Lavage Fluid for Monitoring Cases of Invasive Aspergillosis: What is Its Prognostic Value (ASP)

December 17, 2025 updated by: University Hospital, Strasbourg, France
Aspergillus fumigatus PCR is currently used in conjunction with serum galactomannan to support the diagnosis of invasive aspergillosis or for monitoring at-risk patients not receiving antifungal prophylaxis. A positive result and a high titer are thought to be associated with the advanced stage of the disease and the fungal load. However, there is limited data on this subject, and no study has primarily focused on the variation of PCR levels during treatment and its potential correlation with treatment efficacy.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
        • Principal Investigator:
          • Alia BARTHEL, MD
        • Contact:
        • Principal Investigator:
          • Baptiste Hoellinger, 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Major patient with positive Aspergillus fumigatus PCR on serum or bronchoalveolar lavage fluid at diagnosis, performed at the Strasbourg University Hospital between January 1, 2017, and December 31, 2024.

Description

Inclusion Criteria:

  • Patients aged 18 years or older
  • Positive Aspergillus fumigatus PCR on serum or bronchoalveolar lavage fluid at diagnosis, performed at the Strasbourg University Hospital between January 1, 2017, and December 31, 2024.

Exclusion Criteria:

  • No subsequent Aspergillus fumigatus PCR (>24h)
  • No diagnosis of probable or proven invasive aspergillosis (EORTC/MSGERC 2020 criteria)
  • Effective antifungal treatment against Aspergillus initiated before the first PCR
  • Death <72h after starting antifungal treatment

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
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage)
Time Frame: Day 30 post-antifungal treatment
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage) after the start of treatment
Day 30 post-antifungal treatment

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Actual)

March 17, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9615

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.

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