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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05458752
Other study ID # 2020PI184-Pre-existing datas
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date July 1, 2023

Study information

Verified date July 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date July 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
France Université de Lorraine, CHRU Nancy and APEMAC Vandoeuvre Les Nancy Lorraine

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To describe the age of giv free patients with Pneumocystis jirovecci pneumonia age in years Between the first january 2004 and the 31th december 2021
Secondary To describe the body mass index of HIV free patients with Pneumocystis jirovecci pneumonia BMI in kg/m2 (quanti Between the first january 2004 and the 31th december 2021
Secondary To describe the Charlson comorbidity index of HIV free patients with Pneumocystis jirovecci pneumonia Charlson comorbidity index as a quantitative variable Between the first january 2004 and the 31th december 2021
Secondary To describe the comoribidites of HIV-free patients with Pneumocystis jirovecci pneumonia Comorbidities as categorial variables Between the first january 2004 and the 31th december 2021
Secondary To describe the previous medications used by HIV free patients with Pneumocystis jirovecci pneumonia Medications as categorial variables Between the first january 2004 and the 31th december 2021
Secondary To describe clinical features of Pneumocystis jirovecci pneumonia in HIV-free patients Type of first symptoms as categorial variables Between the first january 2004 and the 31th december 2021
Secondary To describe the date of the first symptoms of Pneumocystis jirovecci pneumonia in HIV-free patients Date of first symptoms as quantitative variable Between the first january 2004 and the 31th december 2021
Secondary To describe the pO2 level of HIV free patients with Pneumocystis jirovecci pneumonia pO2 (in mmHg) Between the first january 2004 and the 31th december 2021
Secondary To describe the PCR level of HIV free patients with Pneumocystis jirovecci pneumonia PCR (mg/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the WBC level of HIV free patients with Pneumocystis jirovecci pneumonia WBC (G/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the creatinine level of HIV free patients with Pneumocystis jirovecci pneumonia Creatinine (µmol/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the LDH level of HIV free patients with Pneumocystis jirovecci pneumonia LDH (MUI/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the albumin level of HIV free patients with Pneumocystis jirovecci pneumonia albumin (g/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the immunoglobulin level of HIV free patients with Pneumocystis jirovecci pneumonia immunoglobulin (g/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the lymphocytes level of HIV free patients with Pneumocystis jirovecci pneumonia lymphocytes (G/L) Between the first january 2004 and the 31th december 2021
Secondary To describe the PCR pneumocystis level of HIV free patients with Pneumocystis jirovecci pneumonia PCR pneumocystis in ct Between the first january 2004 and the 31th december 2021
Secondary To describe the immunofluorescence value of HIV free patients with Pneumocystis jirovecci pneumonia Immunofluorescence as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the specific coloration value of HIV free patients with Pneumocystis jirovecci pneumonia Specific coloration as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the use of nasal canula in HIV free patient with a Pneumocystis jirovecci pneumonia Nasal canula as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the use of high flow oxygenation in HIV free patient with a Pneumocystis jirovecci pneumonia High flow oxygenation as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the use of mechanical ventilation in HIV free patient with a Pneumocystis jirovecci pneumonia Mechanical ventilation as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the duration of hospitalisation of HIV free patients with Pneumocystis carinii pneumonia Duration in days Between the first january 2004 and the 31th december 2021
Secondary To describe the use of cotrimoxazole for HIV free patients with Pneumocystis carinii pneumonia cotrimoxazole as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the use of atovaquone for HIV free patients with Pneumocystis carinii pneumonia atovaquone as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the use of pentamidine for HIV free patients with Pneumocystis carinii pneumonia pentamidine as a categorial variable Between the first january 2004 and the 31th december 2021
Secondary To describe the use of steroïd for HIV free patients with Pneumocystis carinii pneumonia steroïd as a categorial variable Between the first january 2004 and the 31th december 2021
See also
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Not yet recruiting NCT04851015 - Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia Phase 3
Completed NCT05707156 - Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
Recruiting NCT06173453 - Factors Associated With Survival in Patients Having Pneumocystis Jirovecii