NCT06890078

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 17, 2025

Last Update Submit

April 22, 2026

Conditions

Keywords

immunocompromised patientspneumocystis

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

Other: Biological sampling

Interventions

Mouthwash, nasopharyngeal swab, blood sampling

Adults with suspicion of pneumocystis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mouthwash, throat swab, blood samples

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Agathe Vigouroux, MD

CONTACT

Jérôme Lambert, MD PhD

CONTACT

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

Locations