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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03613025
Other study ID # 38RC17.281
Secondary ID 2017-A02651-52
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2018
Est. completion date December 24, 2022

Study information

Verified date March 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 24, 2022
Est. primary completion date December 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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

Locations

Country Name City State
France Grenoble Alpes University Hospital Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard 30 months
Primary Specificity Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard 30 months
Primary Area Under the Curve (AUC) AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard 30 months
Primary 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 30 months
Primary 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 30 months
Secondary 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 30 months
Secondary Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples 30 months
Secondary Duration of anti-PCP treatment (days) Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management 30 months
Secondary 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 30 months
Secondary 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 30 months
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