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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05458752

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumocystis Jirovecii Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Incidence of Pneumocystis jirovecii pneumonia in HIV-free patients [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...)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université de Lorraine, CHRU Nancy and APEMAC	Vandoeuvre Les Nancy	Lorraine	France	54511

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LEFEVRE Benjamin, Doctor, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05458752

Other Study ID Numbers:

2020PI184-Pre-existing datas

First Posted:

Jul 14, 2022

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by LEFEVRE Benjamin, Doctor, Central Hospital, Nancy, France

pneumocystis jirovecii pneumonia

HIV-free patients

Additional relevant MeSH terms:

Pneumonia

Pneumonia, Pneumocystis

Pneumocystis Infections

Study Results

No Results Posted as of Jul 14, 2022