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Use of MULTIplex PCR, procalcitonin and the appearance of sputum to reduce the duration of antibiotic therapy during severe COPD EXAcerbation: a trial controlled, randomized, open, in parallel groups, multicenter

Key facts

Where
Clermont Ferrand Cedex 1, JOSSIGNY, Lille, Lyon Cedex 03, Metz Cedex 03, Montpellier Cedex 5, Nice, Paris, Paris Cedex 20, Reims Cedex, Rouen Cedex és Saint-Mandé, FranciaországSee the 13 sites
Phase
4. fázis

Where in Franciaország

  • University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranciaországNo longer taking part
  • Grand Hôpital de l'Est Francilien - Site de Marne la ValléeJOSSIGNY, FranciaországNo longer taking part
  • CHRU de Lille - Hôpital SalengroLille, FranciaországNo longer taking part
  • Hospital Edouard HerriotLyon Cedex 03, FranciaországNo longer taking part
  • Centre Hospital Region Metz ThionvilleMetz Cedex 03, FranciaországNo longer taking part
  • Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországNo longer taking part
  • Centre Hospitalier Universitaire de NiceNice, FranciaországNo longer taking part
  • Hôpital Bichat - Claude-BernardParis, FranciaországNo longer taking part
  • Hôpital Saint-AntoineParis, FranciaországNo longer taking part
  • Hopital TenonParis Cedex 20, FranciaországNo longer taking part
  • Centre Hospitalier Universitaire ReimsReims Cedex, FranciaországNo longer taking part
  • Centre Hospitalier Universitaire RouenRouen Cedex, FranciaországNo longer taking part
  • Hôpital d'Instructions des Armées BéginSaint-Mandé, FranciaországNo longer taking part

Questions to ask the study team

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Trial details

Who runs it
Assistance Publique Hopitaux De Paris
Trial code
EU 2024-511896-13-00
Record updated
2026. március 20.
Original description
Evaluate the effectiveness in terms of antibiotic sparing of a personalized diagnostic and therapeutic strategy, compared to a usual strategy, during EA-COPD in the ICU/Rea.Read full original descriptionShow less

Use of MULTIplex PCR, procalcitonin and the appearance of sputum to reduce the duration of antibiotic therapy during severe COPD EXAcerbation: a trial controlled, randomized, open, in parallel groups, multicenter (MULTI-EXA)

Evaluate the effectiveness in terms of antibiotic sparing of a personalized diagnostic and therapeutic strategy, compared to a usual strategy, during EA-COPD in the ICU/Rea.

Inclusion: Age ≥ 18 years old; Post-smoking COPD confirmed according to GOLD 2020, whatever the stage (I-IV); Acute exacerbation (defined by the appearance or increase of one or more of the usual signs/symptoms of COPD) with acute respiratory failure requiring admission to the ICU/Resuscitation and mechanical ventilation (invasive or non-invasive or nasal oxygen therapy high flow rate with FiO2 ≥ 50%); Consent (patient, relative or inclusion in emergency situation); Affiliation to a social security scheme.

Exclusion: Antibiotic therapy formally indicated for a suspected or documented extra-respiratory infection; Congenital or acquired immunosuppression (congenital immune deficiency, progressive high-grade hematological malignancy, immunosuppressive drugs in the last 30 days including cytotoxic anti-cancer chemotherapy and anti-rejection drugs, corticosteroid therapy ≥ 20 mg/d of prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4<200/µL in the last 6 months); Delay between admission to hospital and admission to ICU/ICU greater than 3 days; Current pregnancy; Tracheotomy; Bronchial dilatation/cystic fibrosis; Moribund patient (imminent death); Patient deprived of liberty and/or protected by law; Patient already included in MULTI-EXA; Patient already included in a type 1 interventional clinical study (RIPH1) relating to antibiotics.

EU CTIS 2024-511896-13-00