Status:
RECRUITING
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
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
BioMérieux
Conditions:
Acute Exacerbation of COPD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 resp...
Detailed Description
Inclusion (D0\_H0) is performed in ICU/RESUSCITATION. The interval between admission to the hospital and admission to ICU/RESUSCITATION must be maximum 72 hours. Conventional microbiological investiga...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT05280132
Start Date
December 8 2022
End Date
June 1 2026
Last Update
June 25 2025
Active Locations (1)
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1
Intensive care department-Hospital Tenon
Paris, France, 75020