NCT05458752

Brief Summary

Pneumocystis jirovecii pneumonia (PjP) is a rare infectiouse disease with a high level of mortality. PjP is a classical opportunistic infection which concern HIV infected and immunocompromised patients. During the past decade, several therapeutic's progresses have been done in oncology, immunology and hematology. As a consequence, patients benefited of greater treatment efficacy but are exposed to a higher risk of opportunistic infections as PjP. The investigators hypothesis is that PjP incidence increase and its form is depending of underlying immune conditions. The investigators aim to describe its incidence, the PjP forms depending on comorbidities and to identifiy pronostics factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

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

April 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

June 28, 2022

Last Update Submit

July 1, 2023

Conditions

Keywords

pneumocystis jirovecii pneumoniaHIV-free patients

Outcome Measures

Primary Outcomes (1)

  • Incidence of Pneumocystis jirovecii pneumonia in HIV-free patients

    Number of cases / number of patients treated for a predisposing disease (heamotological or imunological disease, or cancer...)

    Between the first january 2004 and the 31th december 2021

Secondary Outcomes (26)

  • To describe the age of giv free patients with Pneumocystis jirovecci pneumonia

    Between the first january 2004 and the 31th december 2021

  • To describe the body mass index of HIV free patients with Pneumocystis jirovecci pneumonia

    Between the first january 2004 and the 31th december 2021

  • To describe the Charlson comorbidity index of HIV free patients with Pneumocystis jirovecci pneumonia

    Between the first january 2004 and the 31th december 2021

  • To describe the comoribidites of HIV-free patients with Pneumocystis jirovecci pneumonia

    Between the first january 2004 and the 31th december 2021

  • To describe the previous medications used by HIV free patients with Pneumocystis jirovecci pneumonia

    Between the first january 2004 and the 31th december 2021

  • +21 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients without HIV-infection hospitalised in Nancy hospital between 2004 and 2021 for Pneumocystis jirovecii pneumonia

You may qualify if:

  • Underlying immune condition at risk of Pneumocystis jirovecii pneumonia excluding HIV infection
  • Clinical, biological and radiological presentation which evoke Pneumocystis jirovecii pneumonia
  • Microbiological confirmation by respiratory specimen analyses ( specific coloration and/or IFI and/or PRC)

You may not qualify if:

  • No microbiological confirmation by respiratory specimen analyses
  • Proved HIV infection
  • Patient denied to particpate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Lorraine, CHRU Nancy and APEMAC

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

MeSH Terms

Conditions

Pneumocystis InfectionsPneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 14, 2022

Study Start

April 1, 2020

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations