Non Invasive Diagnosis of Pneumocystis Pneumonia

University Hospital, Grenoble98 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pneumocystis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sensitivity

Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard

Time frame: 30 months

Specificity

Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard

Time frame: 30 months

Area Under the Curve (AUC)

AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard

Time frame: 30 months

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

Time frame: 30 months

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

Time frame: 30 months

Secondary Outcomes

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

Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples

Time frame: 30 months

Duration of anti-PCP treatment (days)

Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management

Time frame: 30 months

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

Time frame: 30 months

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

Time frame: 30 months

Non Invasive Diagnosis of Pneumocystis Pneumonia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes