RecruitingNot ApplicableNCT05280132

Use of MULTIplex PCR, Procalcitonin, and Sputum Appearance to Reduce Duration of Antibiotic Therapy During Severe COPD EXAcerbation: A Controlled, Randomized, Open-label, Parallel-Group, Multicenter Trial


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

204 participants

Start Date

Dec 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

COPD is a common chronic disease. Its natural course is characterized by Acute exacerbations (AE). This may require hospitalization or even ICU/RESUSCITATION admission. The most common causes are respiratory distress with hypercapnic acidosis that requires mechanical ventilation (Invasive or non-invasive). Lower respiratory tract infections, bacteria and/or viruses are the main pathogenic factors of AE. The treatment of AECOPD is initially symptomatic treatment, combining bronchodilators, ventilatory support (oxygen therapy and/or mechanical ventilation) and respiratory physiotherapy. Systemic corticosteroid therapy is optional. When i) the sputum is purulent and ii) increased dyspnea and / or an increase in sputum volume is observed, antibiotic treatment is recommended for hospitalized patients. Antibiotic therapy is routinely recommended when mechanical ventilation is required. During ICU/RESUSCITATION AECOPD, more than 85% of patients received antibiotic therapy, with a median duration of 8 to 9 days, and the benefit of antibiotic therapy is likely to be limited to infected patients. Suspected or documented lower respiratory tract bacteria, that is, 25% to 50% of patients. This will lead to overuse of antibiotics, which is a problem for patients and the community. A personalized antibiotic strategy could limit this phenomenon, relying on multimodal methods, using aspect of sputum (clinical method), procalcitonin (PCT) (biological method) and the FilmArray ™ Pneumonia Panel extended panel multiplex respiratory PCR Plus (mPCR FA-PPP) (Biomérieux®) (microbiological approach). The hypothesis of this study is that sputum appearance, procalcitonin (PCT) and the FilmArray ™ Pneumonia Panel Plus expanded panel multiplex respiratory PCR (mPCR FA-PPP) (Biomérieux®) could be used in combination , and their results integrated into a decision-making algorithm aimed at personalizing antibiotic therapy and guiding its early termination in patients admitted to ICU/RESUSCITATION due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) to the main benefit of antibiotic savings, and without additional risk to patient safety.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a combination of tools — a rapid lab test (multiplex PCR), a blood marker (procalcitonin), and sputum appearance — can safely shorten the duration of antibiotic treatment during severe COPD flare-ups (exacerbations) that require intensive care. The goal is to reduce overuse of antibiotics without harming patients. **You may be eligible if...** - You are 18 or older with a COPD diagnosis - You are having a severe COPD flare-up that requires ICU admission and breathing support (ventilator or high-flow oxygen) **You may NOT be eligible if...** - You waited more than 3 days after hospital admission before entering the ICU - You have an infection outside the lungs clearly needing antibiotics - You have a severely weakened immune system (e.g., from HIV, certain blood cancers, or high-dose steroids) - You have a tracheostomy, bronchiectasis, or cystic fibrosis - You are pregnant 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPersonalized antibiotic treatment

Personalized antibiotic treatment based on mPCR results, PCT (values and kinetics) and appearance of sputum.

OTHERUsual antibiotic treatment

The antimicrobial therapy is left at the discretion of the physicians, as in usual practice.


Locations(1)

Intensive care department-Hospital Tenon

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05280132


Related Trials