Pneumocystis
Conditions
Brief 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).
Interventions
DIAGNOSTIC_TESTSampling 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
Sponsors
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of the negative predictive value | 30 months | Estimation of the negative predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard |
| Sensitivity | 30 months | Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard |
| Specificity | 30 months | Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard |
| Area Under the Curve (AUC) | 30 months | AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard |
| Estimation of the positive predictive value | 30 months | Estimation of the predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples | 30 months | — |
| Duration of anti-PCP treatment (days) | 30 months | Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management |
| 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 | 30 months | Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management |
| 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 | 30 months | Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management |
Countries
France
Outcome results
None listed