Optimizing the Diagnosis of Pneumocystis in Immunocomprom... | NCT06890078

Studies
Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients

NCT06890078

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Pneumocystis
Immunocompromised Patients

Interventions

Biological sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2025Actual

Primary Completion Date

Jul 8, 2027Estimated

Completion Date

Jul 8, 2027Estimated

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Mar 17, 2025

First Posted Date

Mar 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults with suspicion of pneumocystis			Other: Biological sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological sampling	Other	Mouthwash, nasopharyngeal swab, blood sampling	Adults with suspicion of pneumocystis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Fungal load by qPCR	Quantitative fungal load results obtained by qPCR on nasopharyngeal swab, mouthwash, induced sputum, BAL	At inclusion
Fungal load by serum PCR	Quantitative fungal load results obtained by serum PCR

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with suspected pneumocystis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agathe Vigouroux, MD	Contact	0142494683	+33	agathelaure.vigouroux@aphp.fr
Jérôme Lambert, MD PhD	Contact	+33 1 42 49 97 42	+33	jerome.lambert@u-paris.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Lariboisière AP-HP Maladies infectieuses	Recruiting	Paris			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011020	Pneumonia, Pneumocystis

Ancestor Terms

ID	Term
D008172	Lung Diseases, Fungal
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided