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

Pneumocystis Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077150
• Other study ID #: (4)8414112
• Status: Completed
• Start date: March 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2023
• Source: European Society for Blood and Marrow Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria PCP cases:

• 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 PCP cases:

• 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).

Related Conditions & MeSH terms

• Pneumocystis Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven
France	University of Amiens: CHU Amiens	Amiens
France	Hôpital Henri Mondor	Creteil
France	Hôpital Huriez	Lille
France	Hopital St. Louis	Paris
Germany	University Hospital Eppendorf	Hamburg
Hungary	United St. Istvan and St. Laszlo Hospital	Budapest
Israel	Rambam Medical Center	Haifa
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
European Society for Blood and Marrow Transplantation

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Israel,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-transplant risk factors for PCP infection	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	90 days