Completed

MULTI-CAPCombined 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.

What is being tested

Antibiotic therapy according to the result of mPCR (device)

Device

Who is being recruted

Community-Acquired Pneumonia+3

+ Infections

+ Pneumonia

Over 18 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Interventional

Study Start: October 2018

See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 4, 2018

Actual date on which the first participant was enrolled.

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

Official TitleCombined 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.

NCT03452826

Principal SponsorAssistance Publique - Hôpitaux de Paris

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

411 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Community-Acquired PneumoniaInfectionsPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsCommunity-Acquired Infections

Criteria

2 inclusion criteria required to participate

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.

14 exclusion criteria prevent from participating

Moribund patient or death expected from underlying disease during the current admission;

Pregnancy;

Congenital immunodeficiency;

HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hôpital BICHAT

Paris, FranceOpen Hôpital BICHAT in Google Maps

CompletedOne Study Center