Non Invasive Diagnosis of Pneumocystis Pneumonia

Pneumocystis Clinical Trial

— DANIPOP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613025
• Other study ID #: 38RC17.281
• Secondary ID: 2017-A02651-52
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: December 24, 2022

Study information

• Verified date: March 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 24, 2022
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumocystis
• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Diagnostic Test:
• Sampling 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

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard	30 months
Primary	Specificity	Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard	30 months
Primary	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
Primary	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
Primary	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	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
Secondary	Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples		30 months
Secondary	Duration of anti-PCP treatment (days)	Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management	30 months
Secondary	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	30 months
Secondary	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	30 months