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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020PI184-Pre-existing datas

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.

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