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Completed

NCT Number: NCT05077150

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Gasthuisberg, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Post-transplant risk factors for PCP infection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

European Society for Blood and Marrow Transplantation

Network

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2021
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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