PneumocystisDANIPOPNCT03613025
Non Invasive Diagnosis of Pneumocystis Pneumonia
A study testing Sampling of non-invasive and/or non-targeted respiratory tract specimens in people with Pneumocystis, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis
- What is being tested?
- Sampling of non-invasive and/or non-targeted respiratory tract specimens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2018to 24 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy, breastfeeding
- Deprivation of liberty
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Sampling of non-invasive and/or non-targeted respiratory tract specimens
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of non-invasive and/or non-targeted respiratory tract specimensDiagnostic test
Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP
| Study group | Role | What they receive |
|---|---|---|
| Case : confirmed PCP diagnosis | Other | Sampling of non-invasive and/or non-targeted respiratory tract specimens Receives: 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 Receives: Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Measured: 30 months
Specificity
Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 months
Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples
Measured: 30 months
Duration of anti-PCP treatment (days)
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Measured: 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
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Measured: 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
Impact of PCP diagnosis on non-invasive and/or non-targeted respiratory samples on the patient management
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start25 Jun 2018
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumocystisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613025
- Sponsor's protocol ID
- 38RC17.281
- Other IDs
- 2017-A02651-52
- Acronym
- DANIPOP
- Status last verified
- Mar 2023
- First submitted
- 9 Jul 2018
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03613025
- Acronym / sponsor ID
- DANIPOP / 38RC17.281
- Conditions
- Pneumocystis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case : confirmed PCP diagnosis | Other | Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimensSampling of non-invasive and/or non-targeted respiratory tract specimens |
| Control : non confirmed PCP diagnosis | Other | Diagnostic Test: Sampling of non-invasive and/or non-targeted respiratory tract specimensSampling of non-invasive and/or non-targeted respiratory tract specimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy, breastfeeding
- Deprivation of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of non-invasive and/or non-targeted respiratory tract specimensSampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP | Diagnostic test | Case : confirmed PCP diagnosis, Control : non confirmed PCP diagnosis |
Primary outcome
Sensitivity
Time frame: 30 months
Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Specificity
Time frame: 30 months
Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
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
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
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
5 secondary outcomes
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
Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples
Time frame: 30 months
Duration of anti-PCP treatment (days)
Time frame: 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
Time frame: 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
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling of non-invasive and/or non-targeted respiratory tract specimens in people with Pneumocystis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 30 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.