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| ID | Type | Description | Link |
|---|---|---|---|
| AO 1615-48 | Other Grant/Funding Number | PHRC |
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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
Randomization is performed immediately after the inclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Antibiotic therapy at discretion of ICU physicians | No Intervention | Antibiotic therapy at discretion of ICU physicians |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic therapy according to the result of mPCR (device) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 28 (D28) and 90 days (D90); | Mortality rate at D28 and D90 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François TIMSIT, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital BICHAT | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40663137 | Derived | 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. | |
| 34408046 |
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|
|
| Day 28 |
| Antibiotics duration at D28 | Antibiotics duration at D28 | Day 28 |
| Number of organ-failure free days (based on SOFA) at D28 | Number of organ-failure free days (based on SOFA) at D28 | Day 28 |
| Incidence rates of bacterial superinfections at D28 | Incidence rates of bacterial superinfections at D28 | 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 | 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 | Day 28 |
| Duration of ICU and hospital stay | Duration of ICU and hospital stay | 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; | 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). | 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 | Day 28 |
| Euroquol questionary (EQ-5D-3L) | Euroquol questionary (EQ-5D-3L) | 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. | Day 28 |
| Derived |
| Voiriot 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. |
| 33395094 | Derived | Kerneis 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. |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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