Non Invasive Diagnosis of Pneumocystis Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2022-12-24

Brief Summary

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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).

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Detailed Description

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Conditions

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Pneumocystis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Case : confirmed PCP diagnosis

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

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP

Control : non confirmed PCP diagnosis

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

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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