Community-acquired PneumoniaMULTI-CAPNCT03452826
Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia
A study testing Antibiotic therapy according to the result of mPCR (device) in people with Community-acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Antibiotic therapy according to the result of mPCR (device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2018to 1 Mar 2023
- 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
- Adults (≥18 years) with CAP admitted to the ICU since 18 hours or less; the diagnosis of pneumonia includes two clinical criteria among a temperature > 37.8°C, tachypnea (respiratory rate > 25/min), chest pain, cough, expectoration, localized crackles, with or without signs of pleural effusion, pulse oximetry less than 92% while breathing room air, and a newly-appeared parenchymal infiltrate; the pneumonia is community-acquired if the time between hospital admission and ICU referral is below or equal to 48 hours.
- Informed consent or emergency procedure.
Who cannot join
- Pregnancy;
- Congenital immunodeficiency;
- HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
- Acute hematologic malignancy;
- Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
- Immunosuppressive drugs within the previous 30 days, including anti-cancer chemotherapy and anti-rejection drugs for organ/bone marrow transplant
Show all 14Show fewer
- Corticosteroids ≥ 20 mg/d of prednisone equivalent for more than 14 days;
- chronic obstructive pulmonary disease (COPD) with previous history of colonization/infection with Pseudomonas aeruginosa;
- Tracheostomy;
- Diffuse bronchiectasis, cystic fibrosis;
- Aspiration pneumonia;
- Moribund patient or death expected from underlying disease during the current admission;
- Patient deprived of liberty or under legal protection measure;
- Participation in another interventional trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Use of a Respiratory Broad Panel MULTIplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia: a Multicentre, Parallel-group, Open-label, Randomized Controlled Trial.
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control).
A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days
Read the detailed description
Randomization is performed immediately after the inclusion.
- In the intervention arm, a broad panel respiratory mPCR is performed on a lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum), collected before the 12th hour following inclusion.
- In both arms, an additional lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) is collected for biological studies and banking.
- In the intervention arm, an algorithm of early antibiotic de-escalation and discontinuation is based on the early microbiological results, including the mPCR results, and the procalcitonin value. This algorithm is applied as soon as possible (before the 24th hour following inclusion if possible).
- In the control arm, initial antibiotic therapy is maintained, according to guidelines.
- In both arms, after 72 hours of antibiotic therapy, ICU physicians are advised to use procalcitonin (values and kinetics) to guide antibiotic therapy discontinuation, with a recommended total duration of 7 days, unless otherwise indicated.
- In both arms, a switch to oral therapy is encouraged
- Conditions
- Community-acquired Pneumonia
- Being tested
- Antibiotic therapy according to the result of mPCR (device)
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic therapy according to the result of mPCR (device)Device
Also called Antibiotic therapy to be adapted according to the result of mPCR (device)
- Phone call at D28 and D90, unless the patient is still hospitalized;
- Collection of a respiratory tract sample (either distal, i.e. tracheal aspirate or bronchoalveolar lavage, or proximal, i.e. sputum) for broad panel respiratory mPCR in the intervention arm.
- Collection of an additional respiratory tract sample for biological banking in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic therapy according to the result of mPCR | Experimental | Combined use of a respiratory broad panel Multiplex polymerase chain reaction (mPCR) (performed on a lower respiratory tract sample : bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) and procalcitonin. Receives: Device: Antibiotic therapy according to the result of mPCR (device) |
| Antibiotic therapy at discretion of ICU physicians | No intervention | Antibiotic therapy at discretion of ICU physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy
the number of antibiotic free days at D28, which corresponds to the number of days alive without any at Day 28.
Measured: Day 28
Secondary outcomes (13)
Mortality at 28 (D28) and 90 days (D90);
Mortality rate at D28 and D90
Measured: Day 28 and day 90
Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics
Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics
Measured: Day 28
Antibiotics duration at D28
Antibiotics duration at D28
Measured: Day 28
Number of organ-failure free days (based on SOFA) at D28
Number of organ-failure free days (based on SOFA) at D28
Measured: Day 28
Incidence rates of bacterial superinfections at D28
Incidence rates of bacterial superinfections at D28
Measured: Day 28
Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28
Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28
Measured: Day 28
Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28
Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28
Measured: Day 28
Duration of ICU and hospital stay
Duration of ICU and hospital stay
Measured: Day 90
Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;
Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;
Measured: Day 90
Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).
Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).
Measured: Day 90
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Measured: Day 28
Euroquol questionary (EQ-5D-3L)
Euroquol questionary (EQ-5D-3L)
Measured: Day 90
To assess the operational values of the broad panel mPCR Film Array for the diagnosis of ventilator associated pneumonia (in the intervention group only).
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of ventilator associated pneumonia (in the intervention group only), taking the conventional microbiological tests as reference.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start4 Oct 2018
- Primary completion5 Aug 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François TIMSIT, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452826
- Sponsor's protocol ID
- P160928J
- Other IDs
- AO 1615-48
- Acronym
- MULTI-CAP
- Status last verified
- Oct 2023
- First submitted
- 26 Feb 2018
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voiriot G, Argaud L, Cohen Y, Tuffet S, Chauvelot L, Souweine B, Klouche K, Reignier J, Schwebel C, Rouze A, Mekontso Dessap A, Bohe J, Megarbane B, Carvelli J, Navellou JC, Gibot S, Maury E, Dellamonica J, Dequin PF, Dessajan J, Armand-Lefevre L, Vandenesch F, Verdet C, Durand Zaleski I, Berard L, Rousseau A, Tabassome S, Fartoukh M, Timsit JF; MULTI-CAP collaborative trial group. Combined use of a multiplex PCR and serum procalcitonin to reduce antibiotic exposure in critically ill patients with community-acquired pneumonia: the MULTI-CAP randomized controlled trial. Intensive Care Med. 2025 Aug;51(8):1417-1430. doi: 10.1007/s00134-025-08014-9. Epub 2025 Jul 15.
PubMed 40663137Voiriot G, Fartoukh M, Durand-Zaleski I, Berard L, Rousseau A, Armand-Lefevre L, Verdet C, Argaud L, Klouche K, Megarbane B, Patrier J, Richard JC, Reignier J, Schwebel C, Souweine B, Tandjaoui-Lambiotte Y, Simon T, Timsit JF; MULTI-CAP study group. Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group, open-label, individual randomised trial conducted in French intensive care units. BMJ Open. 2021 Aug 18;11(8):e048187. doi: 10.1136/bmjopen-2020-048187.
PubMed 34408046Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
PubMed 33395094
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Respiratory Broad Panel MULTIplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia: a Multicentre, Parallel-group, Open-label, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03452826
- Acronym / sponsor ID
- MULTI-CAP / P160928J
- Conditions
- Community-acquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 2 Mar 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.
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control).
A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days
Detailed description
Randomization is performed immediately after the inclusion.
- In the intervention arm, a broad panel respiratory mPCR is performed on a lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum), collected before the 12th hour following inclusion.
- In both arms, an additional lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) is collected for biological studies and banking.
- In the intervention arm, an algorithm of early antibiotic de-escalation and discontinuation is based on the early microbiological results, including the mPCR results, and the procalcitonin value. This algorithm is applied as soon as possible (before the 24th hour following inclusion if possible).
- In the control arm, initial antibiotic therapy is maintained, according to guidelines.
- In both arms, after 72 hours of antibiotic therapy, ICU physicians are advised to use procalcitonin (values and kinetics) to guide antibiotic therapy discontinuation, with a recommended total duration of 7 days, unless otherwise indicated.
- In both arms, a switch to oral therapy is encouraged
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic therapy according to the result of mPCR | Experimental | Device: Antibiotic therapy according to the result of mPCR (device)Combined use of a respiratory broad panel Multiplex polymerase chain reaction (mPCR) (performed on a lower respiratory tract sample : bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) and procalcitonin. |
| Antibiotic therapy at discretion of ICU physicians | No intervention | –Antibiotic therapy at discretion of ICU physicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (≥18 years) with CAP admitted to the ICU since 18 hours or less; the diagnosis of pneumonia includes two clinical criteria among a temperature > 37.8°C, tachypnea (respiratory rate > 25/min), chest pain, cough, expectoration, localized crackles, with or without signs of pleural effusion, pulse oximetry less than 92% while breathing room air, and a newly-appeared parenchymal infiltrate; the pneumonia is community-acquired if the time between hospital admission and ICU referral is below or equal to 48 hours.
- Informed consent or emergency procedure.
Key exclusion criteria (14 listed)
- Pregnancy;
- Congenital immunodeficiency;
- HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
- Acute hematologic malignancy;
- Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
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 |
|---|---|---|
| Antibiotic therapy according to the result of mPCR (device)Also: Antibiotic therapy to be adapted according to the result of mPCR (device)* Phone call at D28 and D90, unless the patient is still hospitalized; * Collection of a respiratory tract sample (either distal, i.e. tracheal aspirate or bronchoalveolar lavage, or proximal, i.e. sputum) for broad panel respiratory mPCR in the intervention arm. * Collection of an additional respiratory tract sample for biological banking in both arms. | Device | Antibiotic therapy according to the result of mPCR |
Primary outcome
The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy
Time frame: Day 28
the number of antibiotic free days at D28, which corresponds to the number of days alive without any at Day 28.
13 secondary outcomes
Mortality at 28 (D28) and 90 days (D90);
Time frame: Day 28 and day 90
Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics
Time frame: Day 28
Antibiotics duration at D28
Time frame: Day 28
Number of organ-failure free days (based on SOFA) at D28
Time frame: Day 28
Incidence rates of bacterial superinfections at D28
Time frame: Day 28
Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28
Time frame: Day 28
Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28
Time frame: Day 28
Duration of ICU and hospital stay
Time frame: Day 90
Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;
Time frame: Day 90
Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).
Time frame: Day 90
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Time frame: Day 28
Euroquol questionary (EQ-5D-3L)
Time frame: Day 90
To assess the operational values of the broad panel mPCR Film Array for the diagnosis of ventilator associated pneumonia (in the intervention group only).
Time frame: Day 28
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 18 Oct 2023.
- Derived from this study: PubMed 40663137Voiriot G, Argaud L, Cohen Y, Tuffet S, Chauvelot L, Souweine B, Klouche K, Reignier J, Schwebel C, Rouze A, Mekontso Dessap A, Bohe J, Megarbane B, Carvelli J, Navellou JC, Gibot S, Maury E, Dellamonica J, Dequin PF, Dessajan J, Armand-Lefevre L, Vandenesch F, Verdet C, Durand Zaleski I, Berard L, Rousseau A, Tabassome S, Fartoukh M, Timsit JF; MULTI-CAP collaborative trial group. Combined use of a multiplex PCR and serum procalcitonin to reduce antibiotic exposure in critically ill patients with community-acquired pneumonia: the MULTI-CAP randomized controlled trial. Intensive Care Med. 2025 Aug;51(8):1417-1430. doi: 10.1007/s00134-025-08014-9. Epub 2025 Jul 15.
- Derived from this study: PubMed 34408046Voiriot G, Fartoukh M, Durand-Zaleski I, Berard L, Rousseau A, Armand-Lefevre L, Verdet C, Argaud L, Klouche K, Megarbane B, Patrier J, Richard JC, Reignier J, Schwebel C, Souweine B, Tandjaoui-Lambiotte Y, Simon T, Timsit JF; MULTI-CAP study group. Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group, open-label, individual randomised trial conducted in French intensive care units. BMJ Open. 2021 Aug 18;11(8):e048187. doi: 10.1136/bmjopen-2020-048187.
- Derived from this study: PubMed 33395094Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
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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.
Jean-François TIMSIT, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic therapy according to the result of mPCR (device) in people with Community-acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 14 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 18 Oct 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?
The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03452826, which also lists 3 linked publications.
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 18 Oct 2023.