An interventional study of Personalized antibiotic treatment and Usual antibiotic treatment in Acute Exacerbation of COPD, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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 investigations are left at the discretion of the physicians, and may include blood cultures, L. pneumophila and S. pneumoniae antigens. Usual biology includes procalcitonin measurement. Empirical antimicrobial therapy must be started as soon as possible after inclusion.
Randomization is performed immediately after the inclusion. In the intervention arm, a broad panel respiratory mPCR FA-PPP is performed on respiratory tract sample (tracheal aspirate, BAL or sputum), collected 12 hours after inclusion. An algorithm of early antibiotic adaptation and discontinuation, based on the microbiological results, including the mPCR FA-PPP results, and the procalcitonin values and kinetics and also aspect of sputum will be used. This algorithm will be applied as soon as possible after inclusion, and repeated day after day until D7.
In the control arm, the antimicrobial therapy is left at the discretion of the physicians, as in usual practice.
Evaluation criteria are collected at hospital discharge or at D28, and D90. The vital status may be obtained by phone call at D28 (if the patient has been discharged before D28) and at D90.
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This study's planned enrollment of 204 is above the median of 80 across 732 interventional studies indexed under Disease.
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Exclusion Criteria:
Personalized antibiotic treatment based on mPCR results, PCT (values and kinetics) and appearance of sputum. A broad panel respiratory mPCR FA-PPP is performed on a respiratory tract sample collected 12 hours after inclusion. After inclusion (D0), an algorithm of early antibiotic adaptation and discontinuation will be applied immediately and repeated every day until day 7. This algorithm of early antibiotic adaptation and discontinuation is based on a multimodal approach, using: * The appearance of sputum (clinical approach); * PCT values and kinetics (biological approach); * Results of mPCR FA-PPP (microbiological approach).
Procedure: Personalized antibiotic treatment
Usual antibiotic treatment Left at the discretion of the physician as in usual practice
Other: Usual antibiotic treatment
Personalized antibiotic treatment based on mPCR results, PCT (values and kinetics) and appearance of sputum.
The antimicrobial therapy is left at the discretion of the physicians, as in usual practice.
Number of antibiotic-free days
The number of days alive without antibiotics at Day 28.
Time frame: Day 28
Number of days with antibiotics in survivors at D28
Time frame: Day 28
Number of days with broad spectrum antibiotics in survivors at D28
Time frame: Day 28
Nosocomial pneumonia incidence rate
Time frame: Day 28
Multidrug-resistant bacteria colonization / infection rate
Time frame: Day 28
ICU lengths of stay
Time frame: Day 28
Hospital lengths of stay
Time frame: Day 28
Number of days alive without mechanical ventilation (invasive or non-invasive)
Time frame: Day 28
Incidence rates of Hospital-acquired pneumonia (including ventilator-associated pneumonia)
Time frame: Day 28
Mortality rates (in ICU, in hospital)
Time frame: Day 28 and Day 90
Number of additional AECOPD (requiring hospitalization and / or initiation of systemic corticosteroid therapy and / or antibiotic therapy) after the initial AECOPD
Time frame: Day 90
Time between the initial AECOPD and the following AECOPD (AECOPD requiring hospitalization and / or initiation of systemic corticosteroid therapy and / or antibiotic therapy)
Time frame: Day 90
COPD-related symptoms
Using the COPD Assessment Test (CAT) questionnaire
Time frame: Day 90
Plan to share: Yes — De-identified individual-participant data will be made available outside the primary research group for secondary research purposes like re-analysis, secondary analysis, or meta-analysis, and shared via an online secured platform.
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