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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to improve the way antibiotics are used in patients with severe flare-ups of Chronic Obstructive Pulmonary Disease (COPD). When people with COPD experience acute exacerbations, they often need to be hospitalized and may require breathing support. Antibiotics are usually given to treat infections, but they are often overused, which can lead to problems for both patients and the community. The trial is testing a new approach that combines the appearance of sputum (mucus), a blood test called procalcitonin, and a special test that detects respiratory infections to help doctors decide when antibiotics are truly necessary and when they can be stopped early.

To participate in this trial, you need to be at least 18 years old and have COPD, with a recent severe flare-up that requires intensive care and breathing support. Participants will be monitored closely to see how this new strategy affects their treatment and recovery. The goal is to ensure that patients receive the right treatment while minimizing the unnecessary use of antibiotics, which could help improve overall health outcomes. If you or a loved one is facing a severe COPD exacerbation and meets the eligibility criteria, this trial might be a good option to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• • COPD (according to GOLD 2020), whatever the stage (I-IV)
• • Acute exacerbation (defined as the onset or worsening of one or more of the usual signs/symptoms of COPD) with acute worsening of respiratory symptoms that result in additional therapy) with acute respiratory failure requiring admission to ICU and ventilatory support (invasive mechanical ventilation or non-invasive mechanical ventilation or high-flow nasal oxygen therapy with FiO2 ≥ 50%)
• • Informed consent of patient, patient's immediate family/ or inclusion in an emergency situation
• • Affiliation to a social security
• Exclusion Criteria:
• • The interval between admission to the hospital and admission to ICU more than 3 days
• • Antibiotic therapy clearly needed for a suspected or documented extra-respiratory infection
• • Congenital or acquired immunosuppression (congenital immune deficiency, high-grade hematologic malignancies, use of immunosuppressive drugs in the last 30 days including anti-cancer chemotherapy and antirejection medications, corticosteroid treatment ≥ 20 mg/d prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4 \<200 / µL in the past 6 months)
• • Tracheotomy
• • Bronchiectasis / cystic fibrosis
• • Moribund patient (imminent death)
• • Patient deprived of liberty and / or under legal protection measure
• • Patient already included in MULTI-EXA
• • Patient already included in a type 1 interventional study on antibiotics
• • Ongoing pregnancy