Non Invasive Diagnosis of Pneumocystis Pneumonia (DANIPOP)
Primary Purpose
Pneumocystis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sampling of non-invasive and/or non-targeted respiratory tract specimens
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumocystis
Eligibility Criteria
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
Sites / Locations
- Grenoble Alpes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Case : confirmed PCP diagnosis
Control : non confirmed PCP diagnosis
Arm Description
Sampling of non-invasive and/or non-targeted respiratory tract specimens
Sampling of non-invasive and/or non-targeted respiratory tract specimens
Outcomes
Primary Outcome Measures
Sensitivity
Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Specificity
Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Area Under the Curve (AUC)
AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Estimation of the positive predictive value
Estimation of the predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Estimation of the negative predictive value
Estimation of the negative predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Secondary Outcome Measures
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
Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples
Duration of anti-PCP treatment (days)
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
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
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
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
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Full Information
NCT ID
NCT03613025
First Posted
July 9, 2018
Last Updated
March 23, 2023
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT03613025
Brief Title
Non Invasive Diagnosis of Pneumocystis Pneumonia
Acronym
DANIPOP
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
December 24, 2022 (Actual)
Study Completion Date
December 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumocystis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case : confirmed PCP diagnosis
Arm Type
Other
Arm Description
Sampling of non-invasive and/or non-targeted respiratory tract specimens
Arm Title
Control : non confirmed PCP diagnosis
Arm Type
Other
Arm Description
Sampling of non-invasive and/or non-targeted respiratory tract specimens
Intervention Type
Diagnostic Test
Intervention Name(s)
Sampling of non-invasive and/or non-targeted respiratory tract specimens
Intervention Description
Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Time Frame
30 months
Title
Specificity
Description
Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Time Frame
30 months
Title
Area Under the Curve (AUC)
Description
AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Time Frame
30 months
Title
Estimation of the positive predictive value
Description
Estimation of the predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Time Frame
30 months
Title
Estimation of the negative predictive value
Description
Estimation of the negative predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Time Frame
30 months
Secondary Outcome Measure Information:
Title
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
Title
Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples
Time Frame
30 months
Title
Duration of anti-PCP treatment (days)
Description
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Time Frame
30 months
Title
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
Description
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Time Frame
30 months
Title
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
Description
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Grenoble Alpes University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
Non Invasive Diagnosis of Pneumocystis Pneumonia
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