A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT

Completed

• Conditions: Pneumocystis Pneumonia

• Registration Number: NCT05077150
• Lead Sponsor: European Society for Blood and Marrow Transplantation

Brief Summary

The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.

Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.

Detailed Description

Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP. Knowing this is a non-interventional study, no additional visits or laboratory tests will be performed for the study. Only the available data will be collected.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-01-06
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-transplant risk factors for PCP infection	90 days	To identify pre- and post-transplant factors associated with development of PcP after allogeneic HSCT including: Underlying disease, graft versus host disease, relapse of underlying disease, immune status, co-infections, age

Trial Locations

Locations (9)

University of Amiens: CHU Amiens; 🇫🇷 Amiens, France

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Hopital St. Louis; 🇫🇷 Paris, France

Rambam Medical Center; 🇮🇱 Haifa, Israel

Hôpital Huriez; 🇫🇷 Lille, France

University Hospital Eppendorf; 🇩🇪 Hamburg, Germany

United St. Istvan and St. Laszlo Hospital; 🇭🇺 Budapest, Hungary

University Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway