- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05458752
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
Conditions
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
-
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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