Non Invasive Diagnosis of Pneumocystis Pneumonia (DANIPOP)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Pneumocystis

Treatments: Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimens

Study type: Interventional

Funder types: Other

Identifiers

NCT03613025

2017-A02651-52 (Other Identifier)

38RC17.281

Details and patient eligibility

About

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).

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Case : confirmed PCP diagnosis

Other group

Description:

Sampling of non-invasive and/or non-targeted respiratory tract specimens

Treatment:

Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimens

Control : non confirmed PCP diagnosis

Other group

Description:

Sampling of non-invasive and/or non-targeted respiratory tract specimens

Treatment:

Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimens