Benefits of Pneumocystis jirovecii pneumonia prevention among patients with autoimmune or inflammatory disease treated with prolonged high dose steroids. (PaRADISE)

Study identification

• EU PAS number:
  EUPAS44554
• Study ID:
  44555
• Official title and acronym:
  Benefits of Pneumocystis jirovecii pneumonia prevention among patients with autoimmune or inflammatory disease treated with prolonged high dose steroids. (PaRADISE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Patients with inflammatory autoimmune diseases (IAD) are often severely immunocompromised and exposed to potentially serious infections. Pneumocystis jirovecii (P. jirovecii) is an opportunistic fungus responsible to Pneumocystis jirovecii pneumonia (PJP),especially in immunocompromised patients. PJP induces chronic or acute respiratory failure and can lead to intensive care unit admission and potentially death. Among IAD patients with PJP, rate of mortality is high,varying between 62% to 80%. Primary prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMX) for the majority of patients or aerosolized pentamidine or atovaquone used in case of TMP-SMX intolerance or allergy,is effective to prevent PJP occurrence and reduces its related mortality. Nevertheless, TMP-SMX exposes to potentially serious side effects such as toxidermia, drug-induced liver or renal injury, cytopenia or lupus induction. To date, except for HIV-infected patients, no clear recommendation exists about the use of PJP prophylaxis among patients with IAD. In 2019, prescription of TMP-SMX for PJP prevention among IAD patients remains highly dependent of local practice. This is a retrospective cohort study planned to assess the effect of PJP prophylaxis to prevent PJP among IAD patients treated with prolonged high dose steroids for IAD. Secondary aims are: To determine safety of PJP prophylaxis among patients with IAD and prolonged high dose steroids, globally and by IAD, To describe the use of PJP prevention in France in patients with IAD and prolonged high dose steroids, and factors associated with PJP prevention, To assess the incidence of PJP among patients with IAD and prolonged high dose steroids, by IAD, To identify risk factors for PJP development among patients with IAD and according to each IAD, To describe overall mortality rates and PJP mortality rates in IAD patients, globally and by IAD, To assess the incidence of hospitalizations (and their main cause) in incident IAD patients.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Assistance Publique - Hôpitaux de Paris (AP-HP)

France

Study timelines

Date when funding contract was signed

Planned: 01/01/2020

Actual: 07/01/2020

Study start date

Planned: 31/12/2020

Actual: 01/12/2021

Data analysis start date

Planned: 31/12/2020

Actual: 01/12/2021

Date of final study report

Planned: 31/12/2023

Sources of funding

Other

More details on funding

French Ministry of Health

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable