Non Invasive Diagnosis of Pneumocystis Pneumonia

Not Applicable

Completed

• Conditions: Pneumocystis
• Interventions: Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimens

• Registration Number: NCT03613025
• Lead Sponsor: University Hospital, Grenoble

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Primary Completion: 2022-12-24
• Study Completion: 2022-12-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case : confirmed PCP diagnosis	Sampling of non-invasive and/or non-targeted respiratory tract specimens	Sampling of non-invasive and/or non-targeted respiratory tract specimens
Control : non confirmed PCP diagnosis	Sampling of non-invasive and/or non-targeted respiratory tract specimens	Sampling of non-invasive and/or non-targeted respiratory tract specimens

Primary Outcome Measures

Name	Time	Method
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
Sensitivity	30 months	Sensitivity 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
Specificity	30 months	Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
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

Secondary Outcome Measures

Name	Time	Method
Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples	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	30 months	Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
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
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

Trial Locations

Locations (1)

Grenoble Alpes University Hospital; 🇫🇷 Grenoble, France