Non Invasive Diagnosis of Pneumocystis Pneumonia (DANIPOP)
March 23, 2023 updated by: University Hospital, Grenoble
Performance of Non-targeted and/or Non-invasive Respiratory Samples for the Rapid Diagnosis of Pneumocystis Pneumonia Using the BDMAX TM Molecular Biology Platform (Becton Dickinson)
Incidence and morbi-mortality of Pneumocystis pneumonia (PCP) are increasing. Early and fast diagnosis and treatment improve PCP prognosis. Biological diagnosis is based on the detection of Pneumocystis jirovecii, mainly by PCR, in broncho-alveolar lavage (BAL) obtained from bronchial fibroscopy. However this invasive exam is not always possible in emergency in suspected patient and others non invasive (sputa) and/or non-targeted (bronchial aspiration) are sent to the laboratory (25% of cases, data from the Grenoble University Hospital). Diagnosis performances of these non invasive/non-targeted samples are not clearly established.
In this study, the investigators aimed to establish the diagnosis value of non-invasive and/or non-targeted respiratory samples (oral fluids, sputa and bronchial aspiration) for the PCP diagnosis, compared to the gold-standard (Pneumocystis PCR on BAL, beta-D-glucans testing on serum and radio-clinical records).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grenoble, France, 38043
- GRENOBLE ALPES UNIVERSITY HOSPITAL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Immunocompromised patient with (i) clinical and/or radiological suspicion of PCP, and (ii) bronchial fibroscopy with contributive BAL
- No immediate life-threatening conditions (estimated life expectancy >12h)
- No PCP treatment or PCP treatment < 48h
- Patient hospitalized in the Grenoble Alpes University Hospital with medical insurance
- Informed and written consent of the patient or its related
Exclusion Criteria:
- Pregnancy, breastfeeding
- Exclusion period of another clinical trial
- Deprivation of liberty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Case : confirmed PCP diagnosis
Sampling of non-invasive and/or non-targeted respiratory tract specimens
|
Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP
|
|
Other: Control : non confirmed PCP diagnosis
Sampling of non-invasive and/or non-targeted respiratory tract specimens
|
Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity
Time Frame: 30 months
|
Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
|
30 months
|
|
Specificity
Time Frame: 30 months
|
Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
|
30 months
|
|
Area Under the Curve (AUC)
Time Frame: 30 months
|
AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
|
30 months
|
|
Estimation of the positive predictive value
Time Frame: 30 months
|
Estimation of the predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
|
30 months
|
|
Estimation of the negative predictive value
Time Frame: 30 months
|
Estimation of the negative predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
|
30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-saving (in hours) of PCP diagnosis on non-invasive and/or non-targeted respiratory samples compared to the PCP diagnosis on BAL, taking into account the time needed for bronchial fibroscopy
Time Frame: 30 months
|
30 months
|
|
|
Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples
Time Frame: 30 months
|
30 months
|
|
|
Duration of anti-PCP treatment (days)
Time Frame: 30 months
|
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
|
30 months
|
|
Estimation of the number of days of presumptive anti-PCP treatment that would have been avoided based on a PCP diagnosis on non-invasive and/or non-targeted respiratory samples
Time Frame: 30 months
|
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
|
30 months
|
|
Estimation of the number of patients who would have received an earlier appropriate anti-PCP treatment based on a PCP diagnosis on non-invasive and/or non-targeted respiratory samples
Time Frame: 30 months
|
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
|
30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2018
Primary Completion (Actual)
December 24, 2022
Study Completion (Actual)
December 24, 2022
Study Registration Dates
First Submitted
July 9, 2018
First Submitted That Met QC Criteria
July 27, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC17.281
- 2017-A02651-52 (Other Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.