Using advanced testing to reduce antibiotic use during severe COPD flare-ups
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
NA · Assistance Publique - Hôpitaux de Paris · NCT05280132
This study is testing if a personalized antibiotic treatment for severe COPD flare-ups can help patients recover faster and reduce the time they need antibiotics compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Paris) |
| Trial ID | NCT05280132 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with COPD experiencing acute exacerbations requiring ICU admission and ventilatory support.
Not a fit: Patients with a clear need for antibiotics due to suspected or documented extra-respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce unnecessary antibiotic use and improve recovery times for patients with severe COPD exacerbations.
How similar studies have performed: Other studies have shown promise in using personalized antibiotic strategies in respiratory infections, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Exacerbation of COPD, AECOPD, respiratory multiplex PCR, Appearance of sputum, Procalcitonin, Antibiotics saving, Diagnosis, Treatment