Dataset Information

Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicentre randomized controlled trial.

ABSTRACT:

Objectives

We aimed at assessing the efficacy and safety on antibiotic exposure of a strategy combining a respiratory multiplex PCR (mPCR) with enlarged panel and daily procalcitonin (PCT) measurements, as compared with a conventional strategy, in adult patients who were critically ill with laboratory-confirmed SARS-CoV-2 pneumonia.

Methods

This multicentre, parallel-group, open-label, randomized controlled trial enrolled patients admitted to 13 intensive care units (ICUs) in France. Patients were assigned (1:1) to the control strategy, in which antibiotic streamlining remained at the discretion of the physicians, or interventional strategy, consisting of using mPCR and daily PCT measurements within the first 7 days of randomization to streamline initial antibiotic therapy, with antibiotic continuation encouraged when PCT was >1 ng/mL and discouraged if < 1 ng/mL or decreased by 80% from baseline. All patients underwent conventional microbiological tests and cultures. The primary end point was antibiotic-free days at day 28.

Results

Between April 20th and November 23rd 2020, 194 patients were randomized, of whom 191 were retained in the intention-to-treat analysis. Respiratory bacterial co-infection was detected in 48.4% (45/93) and 21.4% (21/98) in the interventional and control group, respectively. The number of antibiotic-free days was 12.0 (0.0; 25.0) and 14.0 (0.0; 24.0) days, respectively (difference, -2.0, (95% CI, -10.6 to 6.6), p=0.89). Superinfection rates were high (51.6% and 48.5%, respectively). Mortality rates and ICU lengths of stay did not differ between groups.

Discussion

In severe SARS-CoV-2 pneumonia, the mPCR/PCT algorithm strategy did not affect 28-day antibiotics exposure nor the major clinical outcomes, as compared with routine practice.

SUBMITTER: Fartoukh M

PROVIDER: S-EPMC9847221 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicentre randomized controlled trial.

Fartoukh Muriel M Nseir Saad S Mégarbane Bruno B Cohen Yves Y Lafarge Antoine A Contou Damien D Thille Arnaud W AW Galerneau Louis-Marie LM Reizine Florian F Cour Martin M Klouche Kada K Navellou Jean-Christophe JC Bitker Laurent L Rousseau Alexandra A Tuffet Sophie S Simon Tabassome T Voiriot Guillaume G

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases 20230118 6

<h4>Objectives</h4>We aimed at assessing the efficacy and safety on antibiotic exposure of a strategy combining a respiratory multiplex PCR (mPCR) with enlarged panel and daily procalcitonin (PCT) measurements, as compared with a conventional strategy, in adult patients who were critically ill with laboratory-confirmed SARS-CoV-2 pneumonia.<h4>Methods</h4>This multicentre, parallel-group, open-label, randomized controlled trial enrolled patients admitted to 13 intensive care units (ICUs) in Fran ...[more]

PMID: 36681325

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Project description:IntroductionAt the time of the worrying emergence and spread of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotics in patients with community-acquired pneumonia (CAP) is a public health issue. In this context, the combined use of molecular tests and biomarkers for guiding antibiotics discontinuation is attractive. Therefore, we have designed a trial comparing an integrated approach of diagnosis and treatment of severe CAP to usual care.Methods and analysisThe multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a multicentre (n=20), parallel-group, superiority, open-label, randomised trial. Patients are included if adult admitted to intensive care unit for a CAP. Diagnosis of pneumonia is based on clinical criteria and a newly appeared parenchymal infiltrate. Immunocompromised patients are excluded. Subjects are randomised (1:1 ratio) to either the intervention arm (experimental strategy) or the control arm (usual strategy). In the intervention arm, the microbiological diagnosis combines a respiratory multiplex PCR (mPCR) and conventional microbiological investigations. An algorithm of early antibiotic de-escalation or discontinuation is recommended, based on mPCR results and the procalcitonin value. In the control arm, only conventional microbiological investigations are performed and antibiotics de-escalation remains at the clinician's discretion. The primary endpoint is the number of days alive without any antibiotic from the randomisation to day 28. Based on our hypothesis of 2 days gain in the intervention arm, we aim to enrol a total of 450 patients over a 30-month period.Ethics and disseminationThe MULTI-CAP trial is conducted according to the principles of the Declaration of Helsinki, is registered in Clinical Trials and has been approved by the Committee for Protection of Persons and the National French Drug Safety Agency. Written informed consents are obtained from all the patients (or representatives). The results will be disseminated through educational institutions, submitted to peer-reviewed journals for publication and presented at medical congresses.Trial registration numberNCT03452826; Pre-results.

Project description:BackgroundRespiratory infection may account for 30% of acute chest syndrome (ACS) aetiologies. However, antimicrobials are routinely prescribed, and de-escalation and/or discontinuation are challenging. Multiplex Polymerase Chain Reaction (mPCR) with an enlarged respiratory panel might support antimicrobial stewardship, and procalcitonin (PCT) measurements help reduce duration of antibiotic therapy. We hypothesized that a strategy combining the use of mPCR with repeated PCT measurements would reduce antibiotic exposure during ACS.MethodsWe conducted a randomised, controlled, parallel group, open-label study in two French hospitals. Consecutive adult patients with ACS were randomly assigned to the conventional or interventional strategy, where antibiotic therapy was targeted on the results of mPCR performed on lower respiratory tract secretions (LRTS) samples, and antibiotic discontinuation based on PCT values and kinetics at Day 1 (D1), D3 and D7. The primary outcome was the number of days of antibiotic exposure at D28 after randomisation. This trial was registered on ClinicalTrial.gov (NCT03919266) and is closed to recruitment.FindingsFrom June 2020 to September 2022, 72 patients were assigned to the interventional (n = 37) or conventional strategy (n = 35). Despite a higher rate of microbiological documentation with the intervention (n = 25; 67.6% versus n = 13; 37.1%; difference, 30.4%; 95% CI 6.7%-51.5%), antibiotic exposure at D28 was similar between the two strategies (6 days [4.0-8.0] versus 6 days [5.0-9.0], respectively; difference, 0.0 day; 95% CI, -2.1 to 2.1). The time to clinical stability, and ICU and hospital lengths of stay did not differ.InterpretationAs compared with conventional tests, an enlarged respiratory panel mPCR combined with a PCT-guided algorithm did not reduce antibiotic exposure at D28 in adults with ACS.FundingAssistance Publique-Hôpitaux de Paris, AP-HP (CRC180159). A financial support for the multiplex PCR kits used in this study was partially provided by bioMérieux.

Dataset Information

Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicentre randomized controlled trial.

Objectives

Methods

Results

Discussion

Publications

Respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in severe SARS-CoV-2 pneumonia: a multicentre randomized controlled trial.

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