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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06173453
Other study ID # 8722
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date October 10, 2025

Study information

Verified date June 2023
Source University Hospital, Strasbourg, France
Contact François DANION, MD
Phone 33 3 69 55 15 88
Email Francois.danion@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pneumocystis jirovecii is a fungus that can colonize the airways of some patients and be responsible for a disease called pneumocystosis in other patients and mainly in immunocompromised patients. Pneumocystosis was mainly linked to HIV in the 1990s, but with the advent of new immunosuppressive molecules used in cancers or autoimmune diseases and with the increase in the number of transplants, the epidemiology has changed in recent years. Studies on P. jirovecii-related mortality are only based on patients with pneumocystosis. As a result, patients who are simply colonized or patients who are sick but not treated are not taken into account in these studies. The investigators therefore wish to study the overall mortality at six weeks and at three months in all patients with a positive sample for P. jirovecii


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date October 10, 2025
Est. primary completion date August 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adult patients with a positive respiratory sample for P. jirovecii cared for in Strasbourg University Hospitals between 01/01/2016 and 31/12/2018. Positive samples are defined as a direct examination finding cysts or trophozoites after staining with May-Grunewald-Giemsa and/or Gomori-Grocott, a positive P. jirovecii PCR on sputum, tracheal aspirates or bronchial fluid -alveolar - Subject not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: - Subject having expressed its opposition to the reuse of its data for scientific research purposes.

Study Design


Locations

Country Name City State
France Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival at six weeks and three months after infection six weeks after infection
See also
  Status Clinical Trial Phase
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
Completed NCT05458752 - Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients