Community-acquired PneumoniaNCT05624684
Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel in ICU Patients With Severe Pneumonia.
An observational study of Community-acquired Pneumonia and Hospital-acquired Pneumonia, run by Avicenna Military Hospital at 1 site in Morocco.
Trial summary
The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Hospital-acquired Pneumonia, Ventilator Associated Pneumonia
- What is being tested?
- Multiplex respiratory PCR
- How many people
- 210 participants
- Where
- 1 siteMorocco
- Study dates
- 3 Feb 2023to 22 Feb 2024
- Phase
- Observational
- 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
Study population: Critically ill patients with ventilator-associated pneumonia (VAP), community-acquired pneumonia (CAP), or hospital-acquired pneumonia (HAP). For CAP and HAP, only patients under invasive mechanical ventilation will be included.
Who may be able to join
- critically ill adult patients
- clinical, biological, and radiological signs of severe pneumonia.
- community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
- invasive mechanical ventilation.
Who cannot join
- Non-invasive mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Avicenna Military Hospital
Marrakesh, Marrakesh Tensift El Haouz, 40000
About this study
Official title: Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel on the Early Adaptation of Antimicrobial Therapy in ICU Patients With Severe Pneumonia. A Prospective Multicentric Observational Study.
The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia.
Read the detailed description
This is a prospective, observational, multicenter ICU study. Adult patients with severe pneumonia requiring invasive mechanical ventilation will be included. Severe pneumonia consists of 3 categories of pneumonia: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), and ventilator-acquired pneumonia (VAP). The microbiological testing will be performed before antibiotic initiation on tracheobronchial aspirations, protected distal sampling, or mini-bronchoalveolar lavage as part of routine care. No additional samples will becollected for this study. Respiratory samples will be simultaneously tested by conventional microbiological techniques and multiplex respiratory PCR [PCR-RM] (BIOFIRE® FILMARRAY® Pneumonia Panel Plus). Classical microbiological culture (CMC) will be considered the gold standard for microbiological pneumonia diagnosis. The agreement between the results of the Pneumonia Plus® panel and the results of conventional microbial culture (CMC) will be assessed.
An empiric antibiotic therapy will be prescribed according to the local ecology and the protocols of each ICU unit. Two senior experts in each participating center will have to approve the antibiotic prescription. The antibiotic therapy could be modified after the reception of the Mutilpex PCR results by the two senior experts. After the reception of the results of the classic microbiological culture, the previous antibiotic changes will be judged as appropriate or inappropriate by a multidisciplinary team including intensivists, infectious disease specialists, and microbiologists. Appropriate changes include adequacy, de-escalation, and optimization of antibiotic therapy, and inappropriate changes include inadequacy, escalation, and de-optimization.
- Conditions
- Community-acquired Pneumonia, Hospital-acquired Pneumonia, Ventilator Associated Pneumonia
- Being tested
- Multiplex respiratory PCR
- Keywords
- Community-acquired Pneumonia, Hospital-acquired Pneumonia, Ventilator Associated Pneumonia, Multiplex PCR, Antibiotic stewardship
- Medical subject headings
- Community-Acquired Pneumonia, Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex respiratory PCRDiagnostic test
The BIOFIRE® FILMARRAY® Pneumonia plus Panel
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with severe pneumonia | Critically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia. Receives: Diagnostic Test: Multiplex respiratory PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of diagnostic concordance between Classical microbiological cultures and the respiratory multiplex PCR (RM-PCR) and conventional microbiological cultures (CMC) to identify pathogens responsible for severe pneumonia in critically ill patients.
Classical microbiological cultures (CMC) will serve as the gold standard for the comparison between techniques, considering a test result:
- A true positive, when CMC and RM-PCR have identified the same microorganism (CMC+, PCR-RM +).
- A false positive, when RM-PCR detected an organism but not CMC (CMC-, RM-PCR+)
- A true negative, when no method detected any microorganism (CMC-, RM-PCR -)
- A false negative, when CMC but not RM-PCR has detected an organism (CMC+, RM-PCR -).
Sensitivity, specificity, and positive and negative predictive values for the respiratory multiplex PCR will be calculated using the precedent findings.
Measured: through study completion, an average of 6 months
The impact of the respiratory multiplex PCR (RM-PCR) on the appropriateness of empirical antimicrobial therapy.
The proportion of patients for whom the respiratory multiplex PCR (RM-PCR) induces an appropriate change of antibiotic therapy. Appropriate changes include adequacy, de-escalation, and escalation of antibiotic treatment.
- Adequacy is defined as introducing an antibiotic to cover a microorganism that was not adequately treated before the results of RM-PCR.
- Escalation is defined by a widening of the ATB spectrum to cover a pathogen not taken into account or the detection of resistance genes.
- De-escalation is defined as the use of a narrower-spectrum anti-infective or the discontinuation of an ATB combination.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start3 Feb 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicenna Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Aissaoui, MD, Avicenna Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624684
- Sponsor's protocol ID
- MORICUP-PCR study
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The datasets of the study will be available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel on the Early Adaptation of Antimicrobial Therapy in ICU Patients With Severe Pneumonia. A Prospective Multicentric Observational Study.
- ClinicalTrials.gov ID
- NCT05624684
- Acronym / sponsor ID
- MORICUP-PCR study
- Conditions
- Community-acquired Pneumonia, Hospital-acquired Pneumonia, Ventilator Associated Pneumonia
- Keywords
- Community-acquired Pneumonia, Hospital-acquired Pneumonia, Ventilator Associated Pneumonia, Multiplex PCR, Antibiotic stewardship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Avicenna Military HospitalUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 22 Nov 2022 (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.
The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia.
Detailed description
This is a prospective, observational, multicenter ICU study. Adult patients with severe pneumonia requiring invasive mechanical ventilation will be included. Severe pneumonia consists of 3 categories of pneumonia: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), and ventilator-acquired pneumonia (VAP). The microbiological testing will be performed before antibiotic initiation on tracheobronchial aspirations, protected distal sampling, or mini-bronchoalveolar lavage as part of routine care. No additional samples will becollected for this study. Respiratory samples will be simultaneously tested by conventional microbiological techniques and multiplex respiratory PCR [PCR-RM] (BIOFIRE® FILMARRAY® Pneumonia Panel Plus). Classical microbiological culture (CMC) will be considered the gold standard for microbiological pneumonia diagnosis. The agreement between the results of the Pneumonia Plus® panel and the results of conventional microbial culture (CMC) will be assessed.
An empiric antibiotic therapy will be prescribed according to the local ecology and the protocols of each ICU unit. Two senior experts in each participating center will have to approve the antibiotic prescription. The antibiotic therapy could be modified after the reception of the Mutilpex PCR results by the two senior experts. After the reception of the results of the classic microbiological culture, the previous antibiotic changes will be judged as appropriate or inappropriate by a multidisciplinary team including intensivists, infectious disease specialists, and microbiologists. Appropriate changes include adequacy, de-escalation, and optimization of antibiotic therapy, and inappropriate changes include inadequacy, escalation, and de-optimization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients with severe pneumonia | – | Diagnostic Test: Multiplex respiratory PCRCritically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with ventilator-associated pneumonia (VAP), community-acquired pneumonia (CAP), or hospital-acquired pneumonia (HAP). For CAP and HAP, only patients under invasive mechanical ventilation will be included.
Key inclusion criteria (4 listed)
- critically ill adult patients
- clinical, biological, and radiological signs of severe pneumonia.
- community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
- invasive mechanical ventilation.
Key exclusion criteria (1 listed)
- Non-invasive mechanical ventilation.
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 |
|---|---|---|
| Multiplex respiratory PCRThe BIOFIRE® FILMARRAY® Pneumonia plus Panel | Diagnostic test | ICU patients with severe pneumonia |
Primary outcome
The rate of diagnostic concordance between Classical microbiological cultures and the respiratory multiplex PCR (RM-PCR) and conventional microbiological cultures (CMC) to identify pathogens responsible for severe pneumonia in critically ill patients.
Time frame: through study completion, an average of 6 months
Classical microbiological cultures (CMC) will serve as the gold standard for the comparison between techniques, considering a test result: 1. A true positive, when CMC and RM-PCR have identified the same microorganism (CMC+, PCR-RM +). 2. A false positive, when RM-PCR detected an organism but not CMC (CMC-, RM-PCR+) 3. A true negative, when no method detected any microorganism (CMC-, RM-PCR -) 4. A false negative, when CMC but not RM-PCR has detected an organism (CMC+, RM-PCR -). Sensitivity, specificity, and positive and negative predictive values for the respiratory multiplex PCR will be calculated using the precedent findings.
The impact of the respiratory multiplex PCR (RM-PCR) on the appropriateness of empirical antimicrobial therapy.
Time frame: through study completion, an average of 6 months
The proportion of patients for whom the respiratory multiplex PCR (RM-PCR) induces an appropriate change of antibiotic therapy. Appropriate changes include adequacy, de-escalation, and escalation of antibiotic treatment. * Adequacy is defined as introducing an antibiotic to cover a microorganism that was not adequately treated before the results of RM-PCR. * Escalation is defined by a widening of the ATB spectrum to cover a pathogen not taken into account or the detection of resistance genes. * De-escalation is defined as the use of a narrower-spectrum anti-infective or the discontinuation of an ATB combination.
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 23 Feb 2024.
- Individual participant dataSharing planned: Yes. The datasets of the study will be available from the principal investigator on reasonable request.
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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?
An observational study of Community-acquired Pneumonia and Hospital-acquired Pneumonia, run by Avicenna Military Hospital at 1 site in Morocco.
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 4 inclusion and 1 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 23 Feb 2024. 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 Morocco. 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?
The rate of diagnostic concordance between Classical microbiological cultures and the respiratory multiplex PCR (RM-PCR) and conventional microbiological cultures (CMC) to identify pathogens responsible for severe pneumonia in critically ill patients. (time frame: through study completion, an average of 6 months). The study lists 2 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 23 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.