Actively 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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-25
204
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
B
BioMérieux
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates acute exacerbation of chronic obstructive pulmonary disease (AECOPD), a common chronic lung condition that can cause severe respiratory distress requiring hospitalization or intensive care. The study focuses on evaluating a personalized antibiotic strategy combining sputum appearance, procalcitonin levels, and a multiplex respiratory PCR test to guide antibiotic use during severe AECOPD in ICU patients. The goal is to reduce antibiotic overuse while maintaining patient safety. Participants are randomly assigned to one of two groups. The experimental group receives antibiotic treatment guided by an algorithm based on sputum appearance, procalcitonin values and kinetics, and results from the FilmArray Pneumonia Panel Plus multiplex PCR test performed on respiratory samples collected 12 hours after inclusion. This approach aims to adapt and possibly stop antibiotics early up to day 7. The control group receives usual antibiotic care as decided by their physicians. During the study, patients are evaluated at hospital discharge or by day 28 and day 90, with follow-up calls if discharged earlier. Researchers collect data on antibiotic use duration, incidence of pneumonia and resistant bacteria, length of ICU and hospital stays, ventilation-free days, mortality, and COPD symptoms. The primary measure is the number of antibiotic-free days by day 28, assessing both antibiotic savings and safety over a 3-month period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of COPD according to GOLD 2020, any stage (I-IV)
- Acute exacerbation with worsening respiratory symptoms requiring ICU admission and ventilatory support (invasive or non-invasive mechanical ventilation or high-flow oxygen with FiO2 60; 50%)
- Informed consent from patient or family, or emergency inclusion
- Affiliation to social security
You will not qualify if you...
- More than 3 days between hospital admission and ICU admission
- Need for antibiotic therapy for suspected or confirmed non-respiratory infection
- Congenital or acquired immunosuppression (including recent chemotherapy, high-dose corticosteroids, neutropenia, or HIV with low CD4 count)
- Presence of tracheotomy
- Bronchiectasis or cystic fibrosis
- Moribund patient (imminent death)
- Patient under legal protection or deprived of liberty
- Already included in MULTI-EXA or another type 1 antibiotic interventional study
- Ongoing pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 days before ICU admission
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person) in ICU/Resuscitation
Duration - 7 days
Participants receive antibiotic therapy. In the experimental group, antibiotic treatment is personalized based on multiplex PCR results, procalcitonin values and kinetics, and sputum appearance. This algorithm is applied immediately after inclusion and repeated daily until day 7. In the control group, usual antibiotic treatment is provided at the physician's discretion.
Daily visits for treatment and assessment during ICU stay
Duration - Up to 90 days after treatment
Participants are followed to assess health outcomes including antibiotic use, pneumonia incidence, lengths of stay, mechanical ventilation duration, mortality, and COPD symptoms up to 90 days after treatment.
Assessments at hospital discharge or Day 28, and by phone call at Day 28 and Day 90
Trial Site Locations
Total: 1 location
1
Intensive care department-Hospital Tenon
Paris, France, 75020
Actively Recruiting
Research Team
G
Guillaume VOIRIOT, Professor
M
Muriel Fartoukh, PU-PH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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