Using advanced testing to reduce antibiotic use during severe COPD flare-ups

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a personalized antibiotic treatment approach using multiplex PCR, procalcitonin levels, and sputum appearance to optimize antibiotic therapy during acute exacerbations of COPD. Patients admitted to the ICU with severe respiratory failure will be randomized into two groups: one receiving tailored antibiotic treatment based on specific microbiological results and the other receiving standard care as determined by physicians. The study aims to evaluate the impact of this personalized approach on the duration of antibiotic therapy and patient outcomes over a follow-up period. Data will be collected at hospital discharge and at 28 and 90 days post-discharge to assess the effectiveness of the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Intensive care department-Hospital Tenon
  Paris, France Recruiting

Study contacts

• Principal investigator: Guillaume VOIRIOT, Professor — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Guillaume VOIRIOT, Professor
• Email: guillaume.voiriot@aphp.fr
• Phone: 01 56 01 62 63

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.