NCT05452148

Brief Summary

To determine the presence of IMDPH mutants of Pneumocystis jirovecii in solid organ transplant recipient with prior exposition to mycophenolic acid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 4, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

July 6, 2022

Last Update Submit

April 10, 2025

Conditions

TransplantationPulmonary Diseases

Keywords

Pneumocystis jiroveciiIMPDHGenetic variant

Outcome Measures

Primary Outcomes (1)

  • Presence of Pneumocystis IMPDH gene mutant or not

    The main biological parameter which will be measured will be the positive or negative result for the detection of Pneumocystis IMPDH gene mutant

    At patient enrollment

Eligibility Criteria

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

organ transplant recipients vs. non transplant recipient

You may qualify if:

  • \>= 18 years old with PCP diagnoses, organ transplant recipient or not, acceptation to participate

You may not qualify if:

  • \< 18 years old, no acceptation to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brest University Hospital

Brest, 29609, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pneumocystis DNA isolates

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

July 4, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

April 13, 2025

Record last verified: 2025-04

Locations

FR(1)