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NCT Number: NCT03613025

Non Invasive Diagnosis of Pneumocystis Pneumonia

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble Alpes University Hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Sensitivity

    Time frame: 30 months

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

  2. Specificity

    Time frame: 30 months

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

  3. Area Under the Curve (AUC)

    Time frame: 30 months

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

  4. Estimation of the positive predictive value

    Time frame: 30 months

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

  5. Estimation of the negative predictive value

    Time frame: 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 outcomes

  1. 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

    Time frame: 30 months

  2. Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples

    Time frame: 30 months

  3. Duration of anti-PCP treatment (days)

    Time frame: 30 months

    Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management

  4. 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

    Time frame: 30 months

    Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management

  5. 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

    Time frame: 30 months

    Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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)

Acronym: DANIPOP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2018
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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