RecruitingNot ApplicableNCT06301841

An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care

Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care


Sponsor

University Hospital, Caen

Enrollment

64 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a strategy for deciding when to use antibiotics in ICU patients with a flare-up of COPD (chronic obstructive pulmonary disease) combined with pneumonia. The approach uses multiple tests — including biomarkers and imaging — to guide antibiotic decisions, aiming to reduce unnecessary antibiotic use while still treating serious infections effectively. **You may be eligible if...** - You are over 18 years old - You have COPD (diagnosed or suspected) - You have been admitted to the ICU with community-acquired pneumonia confirmed on chest imaging - You were admitted to the hospital within the past 48 hours - You or your representative has provided informed consent **You may NOT be eligible if...** - You have a weakened immune system (e.g., from cancer treatment, HIV, or immune-suppressing medications) - You are pregnant - You have been hospitalized in the past 3 months (nosocomial infection risk) - You are already being treated for another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERexperimental

At day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation. Discontinuation is encouraged in case of no bacteria documentation and a procalcitonin \< 1 ng/L; discontinuation is even encouraged if a viral documentation is concurrently obtained. In case of no bacteria documentation and a procalcitonin \> 1 nd/L, antibiotic continuation is encouraged for additional two days. In case of bacteria documentation, antibiotic continuation is encouraged, but with narrowing the spectrum as much as possible. The duration of antibiotics is based on a procalcitonin algorithm: procalcitonin \< 0.1 nd/l: discontinuation; 0.1 ng/l \< procalcitonin \< 0.25 ng/l: additional 1 day; procalcitonin \> 0.25 ng/l: additional 2 days.


Locations(1)

Medical Intensive Care Unit, CHU Caen

Caen, France

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NCT06301841