CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 411 enrolled
Drug / intervention
Antibiotic therapy according to the result of mPCR (device)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03452826
NCT03452826N/ACompleted

Combined 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.

Assistance Publique - Hôpitaux de Paris·interventional·Posted Mar 2, 2018·Updated Oct 18, 2023

In Brief

A clinical study evaluating Antibiotic therapy according to the result of mPCR (device) for Community-acquired Pneumonia. Completed, enrolled 411 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 2, 2018
Enrollment StartOct 4, 2018
Primary CompletionAug 5, 2022
Study CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.3 years ago

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.