Pneumocystis Jirovecii InfectionPnP-HIV-FreeNCT05458752
Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients
An observational study of Pneumocystis Jirovecii Infection, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumocystis Jirovecii Infection
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients without HIV-infection hospitalised in Nancy hospital between 2004 and 2021 for Pneumocystis jirovecii pneumonia
Who may be able to join
- 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)
Who cannot join
- No microbiological confirmation by respiratory specimen analyses
- Proved HIV infection
- Patient denied to particpate
Trial locations and contacts
1 site in 1 country.
France1 site
Université de Lorraine, CHRU Nancy and APEMAC
Vandœuvre-lès-Nancy, Lorraine, 54511
About this study
Official title: 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.
- Conditions
- Pneumocystis Jirovecii Infection
- Keywords
- pneumocystis jirovecii pneumonia, HIV-free patients
- Medical subject headings
- Pneumocystis Infections, Pneumonia, Pneumocystis
What is being measured
The primary outcome is the main question the study is designed to answer.
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...)
Measured: Between the first january 2004 and the 31th december 2021
Secondary outcomes (26)
To describe the age of giv free patients with Pneumocystis jirovecci pneumonia
age in years
Measured: Between the first january 2004 and the 31th december 2021
To describe the body mass index of HIV free patients with Pneumocystis jirovecci pneumonia
BMI in kg/m2 (quanti
Measured: Between the first january 2004 and the 31th december 2021
To describe the Charlson comorbidity index of HIV free patients with Pneumocystis jirovecci pneumonia
Charlson comorbidity index as a quantitative variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the comoribidites of HIV-free patients with Pneumocystis jirovecci pneumonia
Comorbidities as categorial variables
Measured: Between the first january 2004 and the 31th december 2021
To describe the previous medications used by HIV free patients with Pneumocystis jirovecci pneumonia
Medications as categorial variables
Measured: Between the first january 2004 and the 31th december 2021
To describe clinical features of Pneumocystis jirovecci pneumonia in HIV-free patients
Type of first symptoms as categorial variables
Measured: 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
Date of first symptoms as quantitative variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the pO2 level of HIV free patients with Pneumocystis jirovecci pneumonia
pO2 (in mmHg)
Measured: Between the first january 2004 and the 31th december 2021
To describe the PCR level of HIV free patients with Pneumocystis jirovecci pneumonia
PCR (mg/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the WBC level of HIV free patients with Pneumocystis jirovecci pneumonia
WBC (G/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the creatinine level of HIV free patients with Pneumocystis jirovecci pneumonia
Creatinine (µmol/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the LDH level of HIV free patients with Pneumocystis jirovecci pneumonia
LDH (MUI/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the albumin level of HIV free patients with Pneumocystis jirovecci pneumonia
albumin (g/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the immunoglobulin level of HIV free patients with Pneumocystis jirovecci pneumonia
immunoglobulin (g/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the lymphocytes level of HIV free patients with Pneumocystis jirovecci pneumonia
lymphocytes (G/L)
Measured: Between the first january 2004 and the 31th december 2021
To describe the PCR pneumocystis level of HIV free patients with Pneumocystis jirovecci pneumonia
PCR pneumocystis in ct
Measured: Between the first january 2004 and the 31th december 2021
To describe the immunofluorescence value of HIV free patients with Pneumocystis jirovecci pneumonia
Immunofluorescence as a categorial variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the specific coloration value of HIV free patients with Pneumocystis jirovecci pneumonia
Specific coloration as a categorial variable
Measured: 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
Nasal canula as a categorial variable
Measured: 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
High flow oxygenation as a categorial variable
Measured: 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
Mechanical ventilation as a categorial variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the duration of hospitalisation of HIV free patients with Pneumocystis carinii pneumonia
Duration in days
Measured: Between the first january 2004 and the 31th december 2021
To describe the use of cotrimoxazole for HIV free patients with Pneumocystis carinii pneumonia
cotrimoxazole as a categorial variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the use of atovaquone for HIV free patients with Pneumocystis carinii pneumonia
atovaquone as a categorial variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the use of pentamidine for HIV free patients with Pneumocystis carinii pneumonia
pentamidine as a categorial variable
Measured: Between the first january 2004 and the 31th december 2021
To describe the use of steroïd for HIV free patients with Pneumocystis carinii pneumonia
steroïd as a categorial variable
Measured: Between the first january 2004 and the 31th december 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Apr 2020
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis Jirovecii InfectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEFEVRE Benjamin, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458752
- Sponsor's protocol ID
- 2020PI184-Pre-existing datas
- Acronym
- PnP-HIV-Free
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients : a Prognostic Observational Retrospective Monocentre Study
- ClinicalTrials.gov ID
- NCT05458752
- Acronym / sponsor ID
- PnP-HIV-Free / 2020PI184-Pre-existing datas
- Conditions
- Pneumocystis Jirovecii Infection
- Keywords
- pneumocystis jirovecii pneumonia, HIV-free patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients without HIV-infection hospitalised in Nancy hospital between 2004 and 2021 for Pneumocystis jirovecii pneumonia
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- No microbiological confirmation by respiratory specimen analyses
- Proved HIV infection
- Patient denied to particpate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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...)
26 secondary outcomes
To describe the age of giv free patients with Pneumocystis jirovecci pneumonia
Time frame: 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
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
To describe the comoribidites of HIV-free patients with Pneumocystis jirovecci pneumonia
Time frame: 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
To describe clinical features of Pneumocystis jirovecci pneumonia in HIV-free patients
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Pneumocystis Jirovecii Infection
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Not yet recruitingObservational study
TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
Not yet recruitingPhase 4
Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation
Pneumocystis Jirovecii Pneumonia, Kidney Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis Jirovecii Infection, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pneumocystis jirovecii pneumonia in HIV-free patients (time frame: Between the first january 2004 and the 31th december 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.