Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients (PnP-HIV-Free)

July 1, 2023 updated by: LEFEVRE Benjamin, Central Hospital, Nancy, France

Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients : a Prognostic Observational Retrospective Monocentre Study

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lorraine
      • Vandoeuvre Les Nancy, Lorraine, France, 54511
        • Université de Lorraine, CHRU Nancy and APEMAC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pneumocystis jirovecii pneumonia in HIV-free patients
Time Frame: Between the first january 2004 and the 31th december 2021
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the age of giv free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
age in years
Between the first january 2004 and the 31th december 2021
To describe the body mass index of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
BMI in kg/m2 (quanti
Between the first january 2004 and the 31th december 2021
To describe the Charlson comorbidity index of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Charlson comorbidity index as a quantitative variable
Between the first january 2004 and the 31th december 2021
To describe the comoribidites of HIV-free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Comorbidities as categorial variables
Between the first january 2004 and the 31th december 2021
To describe the previous medications used by HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Medications as categorial variables
Between the first january 2004 and the 31th december 2021
To describe clinical features of Pneumocystis jirovecci pneumonia in HIV-free patients
Time Frame: Between the first january 2004 and the 31th december 2021
Type of first symptoms as categorial variables
Between the first january 2004 and the 31th december 2021
To describe the date of the first symptoms of Pneumocystis jirovecci pneumonia in HIV-free patients
Time Frame: Between the first january 2004 and the 31th december 2021
Date of first symptoms as quantitative variable
Between the first january 2004 and the 31th december 2021
To describe the pO2 level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
pO2 (in mmHg)
Between the first january 2004 and the 31th december 2021
To describe the PCR level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
PCR (mg/L)
Between the first january 2004 and the 31th december 2021
To describe the WBC level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
WBC (G/L)
Between the first january 2004 and the 31th december 2021
To describe the creatinine level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Creatinine (µmol/L)
Between the first january 2004 and the 31th december 2021
To describe the LDH level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
LDH (MUI/L)
Between the first january 2004 and the 31th december 2021
To describe the albumin level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
albumin (g/L)
Between the first january 2004 and the 31th december 2021
To describe the immunoglobulin level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
immunoglobulin (g/L)
Between the first january 2004 and the 31th december 2021
To describe the lymphocytes level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
lymphocytes (G/L)
Between the first january 2004 and the 31th december 2021
To describe the PCR pneumocystis level of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
PCR pneumocystis in ct
Between the first january 2004 and the 31th december 2021
To describe the immunofluorescence value of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Immunofluorescence as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the specific coloration value of HIV free patients with Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Specific coloration as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the use of nasal canula in HIV free patient with a Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Nasal canula as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the use of high flow oxygenation in HIV free patient with a Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
High flow oxygenation as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the use of mechanical ventilation in HIV free patient with a Pneumocystis jirovecci pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Mechanical ventilation as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the duration of hospitalisation of HIV free patients with Pneumocystis carinii pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
Duration in days
Between the first january 2004 and the 31th december 2021
To describe the use of cotrimoxazole for HIV free patients with Pneumocystis carinii pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
cotrimoxazole as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the use of atovaquone for HIV free patients with Pneumocystis carinii pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
atovaquone as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the use of pentamidine for HIV free patients with Pneumocystis carinii pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
pentamidine as a categorial variable
Between the first january 2004 and the 31th december 2021
To describe the use of steroïd for HIV free patients with Pneumocystis carinii pneumonia
Time Frame: Between the first january 2004 and the 31th december 2021
steroïd as a categorial variable
Between the first january 2004 and the 31th december 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumocystis Jirovecii Infection

3
Subscribe