NCT03613025

Non Invasive Diagnosis of Pneumocystis Pneumonia

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pneumocystis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-25
• Primary completion: 2022-12-24
• Completion: 2022-12-24
• First posted: 2018-08-02
• Last updated: 2023-03-24

Locations

1 site across 1 country: France