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

NCT07313527 | Recruiting

• 1 other identifier: 9615
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Pulmonary Aspergillosis

Keywords

Invasive Pulmonary Aspergillosis; Aspergillus fumigatus PCR; Bronchoalveolar lavage fluid

Outcome Measures

Primary Outcomes (1)

• Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage)

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

baptiste Hoellinger, MD

CONTACT

33 3 69 55 05 45; baptiste.hoellinger@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: March 17, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)