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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
EU CTIS ID: 2024-511896-13-00
What this study is testing
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.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Delay between admission to hospital and admission to ICU/ICU greater than 3 days
- Current pregnancy.
- 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)
- Tracheotomy
- Bronchial dilatation/cystic fibrosis
See the full eligibility criteria
- 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.
- Delay between admission to hospital and admission to ICU/ICU greater than 3 days
- Current pregnancy.
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.