Non Invasive Diagnosis of Pneumocystis Pneumonia

NCT03613025 | Completed

• 2 other identifiers: 38RC17.2812017-A02651-52
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumocystis

Outcome Measures

Primary Outcomes (5)

• Sensitivity

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

  30 months

• Specificity

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

  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

  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

  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

  30 months

Secondary Outcomes (5)

• 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

• 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

• 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

Study Arms (2)

Case : confirmed PCP diagnosis

OTHER

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

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

Control : non confirmed PCP diagnosis

OTHER

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

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

Interventions

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

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

Case : confirmed PCP diagnosis; Control : non confirmed PCP diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy, breastfeeding
• Deprivation of liberty

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 2, 2018
• Study Start: June 25, 2018
• Primary Completion: December 24, 2022
• Study Completion: December 24, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

FR (1)