Abstract
Introduction
At 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 analysis
The 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 dissemination
The 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 number
NCT03452826; Pre-results.
Funder
Ministère
des Affaires Sociales et de la Santé
Cited by
13 articles.
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