Better testing for Pneumocystis in people with weakened immune systems
Optimisation du Diagnostic de Pneumocystose Chez Les Patients Immunodéprimés
This project will try a new qPCR test on non-invasive respiratory samples to see if it can detect Pneumocystis in immunocompromised adults compared with standard reference tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 4 sites (Paris and 3 other locations) |
| Trial ID | NCT06890078 on ClinicalTrials.gov |
What this trial studies
This observational protocol will collect biological samples (induced sputum and bronchoalveolar lavage when clinically indicated) from immunocompromised adults with suspected Pneumocystis pneumonia. qPCR will be performed on non-invasive samples and results compared to reference techniques from BAL or induced sputum. Key exclusions include more than 72 hours of prior Pneumocystis treatment, pregnancy or breastfeeding, and persons deprived of liberty or unable to give non-opposition/consent. The goal is to determine whether non-invasive qPCR can reliably provide a positive diagnosis and reduce the need for invasive bronchoscopic sampling.
Who should consider this trial
Good fit: Adults who are immunocompromised with suspected Pneumocystis pneumonia who are scheduled for bronchoscopy with BAL or for induced sputum, who have not received more than 72 hours of Pneumocystis treatment and can give non-opposition/consent.
Not a fit: Patients already treated for more than 72 hours, children, pregnant or breastfeeding people, and those unable to give consent or deprived of liberty are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could allow accurate diagnosis from less invasive samples, reducing bronchoscopy procedures and speeding appropriate treatment.
How similar studies have performed: Prior work has shown qPCR can detect Pneumocystis in respiratory samples with good sensitivity, but findings vary by sample type and clinical setting so non-invasive approaches remain under active validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris and 3 other locations
- Hôpital Lariboisière AP-HP Maladies infectieuses — Paris, France (Recruiting)
- Hôpital Saint Louis AP-HP Maladies infectieuses — Paris, France (Recruiting)
- Hôpital Saint Louis AP-HP Réanimation — Paris, France (Recruiting)
- Hôpital Saint-Louis AP-HP Pneumologie — Paris, France (Recruiting)
Study contacts
- Study coordinator: Agathe Vigouroux, MD
- Email: agathelaure.vigouroux@aphp.fr
- Phone: 0142494683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.