- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- University Hospital Gasthuisberg
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Amiens, France, 80054
- University of Amiens: CHU Amiens
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Creteil, France, 94010
- Hopital Henri Mondor
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Lille, France, F-59037
- Hopital Huriez
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Paris, France, 75475
- Hopital St. Louis
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Hamburg, Germany, 20251
- University Hospital Eppendorf
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Budapest, Hungary, 1097
- United St. Istvan and St. Laszlo Hospital
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Haifa, Israel, 31096
- Rambam Medical Center
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Oslo, Norway, PB 4950
- Oslo University Hospital, Rikshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
All patients who have received an allogeneic HSCT during the last 24 months and who have a BAL fluid positive for Pneumocystis jirovecii (qPCR or IF or cytology) during the study period will be included, irrespectively of age, transplant characteristics and irrespectively to the fact that the patient has been treated for PcP or not.
Assuming an incidence of 3% after allogeneic HSCT, a total number of 3 300 allogeneic transplant (roughly 100 centers) would allow to expect 100 cases of PcP.
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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. |
Controls
Controls are matched to case on Centre and HSCT date and if possible on gender and date of birth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Post-transplant risk factors for PCP infection
Time Frame: 90 days
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Christine Robin, MD, Hematology Department, Pr Cordonnier. henri Mondor University Hospital
- Study Chair: Simone Cesaro, MD, Paediatric Haematology Oncology. Policlinico G.B. Rossi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- (4)8414112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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