Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia

NCT03452826 | Completed

• 2 other identifiers: P160928JAO 1615-48
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

Brief 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). A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Mortality at 28 (D28) and 90 days (D90);

  Day 28 and day 90

• Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics

  Day 28

• Antibiotics duration at D28

  Day 28

• Number of organ-failure free days (based on SOFA) at D28

  Day 28

• Incidence rates of bacterial superinfections at D28

  Day 28

Study Arms (2)

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.

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

Interventions

Antibiotic therapy according to the result of mPCR (device) 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.

Also known as: Antibiotic therapy to be adapted according to the result of mPCR (device)

Antibiotic therapy according to the result of mPCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital BICHAT

Paris, 75018, France

Location

Related Publications (3)

• 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.

  PMID: 40663137 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.

  PMID: 34408046 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.

  PMID: 33395094 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Jean-François TIMSIT, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: October 4, 2018
• Primary Completion: August 5, 2022
• Study Completion: March 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

FR (1)