About this trial
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 respiratory distress with hypercapnic acidosis that requires mechanical ventilation (Invasive or non-invasive). Lower respiratory tract infections, bacteria and/or viruses are the main pathogenic factors of AE. The treatment of AECOPD is initially symptomatic treatment, combining bronchodilators, ventilatory support (oxygen therapy and/or mechanical ventilation) and respiratory physiotherapy. Systemic corticosteroid therapy is optional. When i) the sputum is purulent and ii) increased dyspnea and / or an increase in sputum volume is observed, antibiotic treatment is recommended for hospitalized patients. Antibiotic therapy is routinely recommended when mechanical ventilation is required.
During ICU/RESUSCITATION AECOPD, more than 85% of patients received antibiotic therapy, with a median duration of 8 to 9 days, and the benefit of antibiotic therapy is likely to be limited to infected patients. Suspected or documented lower respiratory tract bacteria, that is, 25% to 50% of patients. This will lead to overuse of antibiotics, which is a problem for patients and the community.
A personalized antibiotic strategy could limit this phenomenon, relying on multimodal methods, using aspect of sputum (clinical method), procalcitonin (PCT) (biological method) and the FilmArray ™ Pneumonia Panel extended panel multiplex respiratory PCR Plus (mPCR FA-PPP) (Biomérieux®) (microbiological approach).
The hypothesis of this study is that sputum appearance, procalcitonin (PCT) and the FilmArray ™ Pneumonia Panel Plus expanded panel multiplex respiratory PCR (mPCR FA-PPP) (Biomérieux®) could be used in combination , and their results integrated into a decision-making algorithm aimed at personalizing antibiotic therapy and guiding its early termination in patients admitted to ICU/RESUSCITATION due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) to the main benefit of antibiotic savings, and without additional risk to patient safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Personalized antibiotic treatment
Procedure/SurgeryPersonalized antibiotic treatment based on mPCR results, PCT (values and kinetics) and appearance of sputum.
Usual antibiotic treatment
Other interventionThe antimicrobial therapy is left at the discretion of the physicians, as in usual practice.
Treatment groups
Trial outcomes
Primary outcomes
Number of antibiotic-free days
The number of days alive without antibiotics at Day 28.
Secondary outcomes
Number of days with antibiotics in survivors at D28
Number of days with broad spectrum antibiotics in survivors at D28
Nosocomial pneumonia incidence rate
Multidrug-resistant bacteria colonization / infection rate
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
BioMérieux
Collaborator