Clinical trial NCT03613025: Non Invasive Diagnosis of Pneumocystis Pneumonia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumocystis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity
timeFrame: 30 months
measure: Specificity
timeFrame: 30 months
measure: Area Under the Curve (AUC)
timeFrame: 30 months
measure: Estimation of the positive predictive value
timeFrame: 30 months
measure: Estimation of the negative predictive value
timeFrame: 30 months
Secondary outcomes:
measure: 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
timeFrame: 30 months
measure: Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples
timeFrame: 30 months
measure: Duration of anti-PCP treatment (days)
timeFrame: 30 months
measure: 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
timeFrame: 30 months
measure: 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
timeFrame: 30 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
Study officials:
References: