Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients (OPTIJIROVEC)

April 22, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés

Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

240

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

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Hôpital Lariboisière AP-HP Maladies infectieuses
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Saint Louis AP-HP Maladies infectieuses
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Saint Louis AP-HP Réanimation
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Saint-Louis AP-HP Pneumologie
        • Contact:

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients with suspected pneumocystis

Description

Inclusion Criteria:

  • adult patients with suspected pneumocystis
  • with an indication for bronchial fibroscopy for BAL or induced sputum
  • no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition

Exclusion Criteria:

  • Pneumocystis treated for more than 72 hours
  • pregnancy/breast-feeding
  • adult patients deprived of liberty, protected

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with suspicion of pneumocystis
Other: Biological sampling
Mouthwash, nasopharyngeal swab, blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pearson correlation coefficient
Time Frame: At inclusion
Pearson correlation coefficient between the fungal load obtained by PCR on nasopharyngeal swabs nasopharyngeal swab and buccal lavage and that obtained by reference samples (induced sputum or BAL) in patients with confirmed PcP.
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fungal load by qPCR
Time Frame: At inclusion
Quantitative fungal load results obtained by qPCR on nasopharyngeal swab, mouthwash, induced sputum, BAL
At inclusion
Fungal load by serum PCR
Time Frame: At inclusion
Quantitative fungal load results obtained by serum PCR
At inclusion
Beta D glucan blood levels
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

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)

July 8, 2025

Primary Completion (Estimated)

July 8, 2027

Study Completion (Estimated)

July 8, 2027

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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