Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2022
juin 2026
17 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GRAND HOPITAL DE L'EST FRANCILIEN | VOIRIOT Guillaume | 25/10/2025 09:49:32 | Contacter | ||
| HIA BEGIN | VOIRIOT Guillaume | 25/10/2025 09:49:32 | Contacter | ||
| HOPITAL FOCH | VOIRIOT Guillaume | 25/10/2025 09:49:32 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 25/10/2025 09:49:33 | Contacter | |||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Tenon | |||||
Critères
Tous
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
- 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
- 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