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

NCT ID: NCT05077150

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-05-31

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.

Conditions

Pneumocystis Pneumonia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PCP cases

Any allogeneic HSCT recipient who, during the 1-year study period, underwent a BAL from the day of transplant, and whose BAL fluid was positive for PcP: either by qPCR alone, or positive cytology or IF, irrespectively of clinical presentation, imaging, co-infection and PcP treatment. Only first episode of PcP will be included (incident cases).

Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP.

No interventions assigned to this group

Controls

Controls are matched to case on Centre and HSCT date and if possible on gender and date of birth.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Allogeneic HSCT within the previous 24 months
• New case (first onset) of PcP documented in a BAL fluid, whatever the positive diagnostic test (cytology or IF or PCR) and whatever the presentation and treatment
• Any age
• Pre or post-transplant signed informed consent to enter the data in the EBMT registry

Exclusion Criteria

• Autologous HSCT
• Allogeneic HSCT recipient transplanted more than 24 months at time of the onset of PcP
• Second episode of PcP since allogeneic HSCT (patients who had experienced PcP before the allogeneic HSCT are not excluded).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Robin, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology Department, Pr Cordonnier. henri Mondor University Hospital

Simone Cesaro, MD

Role: STUDY_CHAIR

Paediatric Haematology Oncology. Policlinico G.B. Rossi

Locations

University Hospital Gasthuisberg

Leuven, , Belgium

University of Amiens: CHU Amiens

Amiens, , France

Hôpital Henri Mondor

Créteil, , France

Hôpital Huriez

Lille, , France

Hopital St. Louis

Paris, , France

University Hospital Eppendorf

Hamburg, , Germany

United St. Istvan and St. Laszlo Hospital

Budapest, , Hungary

Rambam Medical Center

Haifa, , Israel

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Countries

Belgium; France; Germany; Hungary; Israel; Norway

Other Identifiers

(4)8414112

Identifier Type: -

Identifier Source: org_study_id