Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients
OPTIJIROVEC
Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés
1 other identifier
observational
240
1 country
4
Brief Summary
Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 21, 2025
CompletedStudy Start
First participant enrolled
July 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 8, 2027
April 23, 2026
April 1, 2026
2 years
March 17, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pearson correlation coefficient
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 Outcomes (3)
Fungal load by qPCR
At inclusion
Fungal load by serum PCR
At inclusion
Beta D glucan blood levels
At inclusion
Study Arms (1)
Adults with suspicion of pneumocystis
Interventions
Mouthwash, nasopharyngeal swab, blood sampling
Eligibility Criteria
Adult patients with suspected pneumocystis
You may qualify if:
- 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
You may not qualify if:
- Pneumocystis treated for more than 72 hours
- pregnancy/breast-feeding
- adult patients deprived of liberty, protected
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hôpital Lariboisière AP-HP Maladies infectieuses
Paris, France
Hôpital Saint Louis AP-HP Maladies infectieuses
Paris, France
Hôpital Saint Louis AP-HP Réanimation
Paris, France
Hôpital Saint-Louis AP-HP Pneumologie
Paris, France
Biospecimen
Mouthwash, throat swab, blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2025
First Posted
March 21, 2025
Study Start
July 8, 2025
Primary Completion (Estimated)
July 8, 2027
Study Completion (Estimated)
July 8, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04