Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05280132

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

181 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

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of COPD according to GOLD 2020, any stage (I-IV)
  • Acute exacerbation of COPD with respiratory failure needing ICU admission and ventilatory support (invasive or non-invasive mechanical ventilation or high-flow nasal oxygen with FiO2 60;50%)
  • Patient or immediate family provides informed consent or inclusion in emergency situation
  • Affiliated to social security
Not Eligible

You will not qualify if you...

  • More than 3 days between hospital admission and ICU admission
  • Need for antibiotics for suspected or confirmed infections outside the respiratory tract
  • Congenital or acquired immunosuppression, including recent immunosuppressive drugs, high-dose corticosteroids, neutropenia, or HIV with low CD4 count
  • Presence of tracheotomy
  • Bronchiectasis or cystic fibrosis
  • Imminent death or moribund state
  • Legal protection status or deprivation of liberty
  • Previous participation in MULTI-EXA trial
  • Previous participation in interventional antibiotic study
  • Current pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Intensive care department-Hospital Tenon

Paris, France, 75020

Actively Recruiting

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Research Team

G

Guillaume VOIRIOT, Professor

CONTACT

M

Muriel Fartoukh, PU-PH

CONTACT

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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