Acute Exacerbation of COPDMULTI-EXANCT05280132
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
A study testing Personalized antibiotic treatment and Usual antibiotic treatment in people with Acute Exacerbation of COPD, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Personalized antibiotic treatment and Usual antibiotic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Intensive care department-Hospital Tenon
Paris, 75020
Guillaume VOIRIOT, Professor, 01 56 01 62 63, guillaume.voiriot@aphp.fr
Muriel FARTOUKH, PU-PH, 01 56 01 65 72, muriel.fartoukh@aphp.fr
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Personalized antibiotic treatment, Usual antibiotic treatment
- Keywords
- AECOPD, respiratory multiplex PCR, Appearance of sputum, Procalcitonin, Antibiotics saving, Diagnosis, Treatment
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized antibiotic treatmentProcedure or surgery
Personalized antibiotic treatment based on mPCR results, PCT (values and kinetics) and appearance of sputum.
Usual antibiotic treatmentOther
The antimicrobial therapy is left at the discretion of the physicians, as in usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Personalized strategy | Experimental | 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). Receives: Procedure: Personalized antibiotic treatment |
| Usual strategy | Other | Usual antibiotic treatment
Left at the discretion of the physician as in usual practice Receives: Other: Usual antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of antibiotic-free days
The number of days alive without antibiotics at Day 28.
Measured: Day 28
Secondary outcomes (12)
Number of days with antibiotics in survivors at D28
Measured: Day 28
Number of days with broad spectrum antibiotics in survivors at D28
Measured: Day 28
Nosocomial pneumonia incidence rate
Measured: Day 28
Multidrug-resistant bacteria colonization / infection rate
Measured: Day 28
ICU lengths of stay
Measured: Day 28
Hospital lengths of stay
Measured: Day 28
Number of days alive without mechanical ventilation (invasive or non-invasive)
Measured: Day 28
Incidence rates of Hospital-acquired pneumonia (including ventilator-associated pneumonia)
Measured: Day 28
Mortality rates (in ICU, in hospital)
Measured: 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
Measured: 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)
Measured: Day 90
COPD-related symptoms
Using the COPD Assessment Test (CAT) questionnaire
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start8 Dec 2022
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Guillaume VOIRIOT, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280132
- Sponsor's protocol ID
- APHP210085
- Other IDs
- 2021-005435-23
- Acronym
- MULTI-EXA
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05280132
- Acronym / sponsor ID
- MULTI-EXA / APHP210085
- Conditions
- Acute Exacerbation of COPD
- Keywords
- AECOPD, respiratory multiplex PCR, Appearance of sputum, Procalcitonin, Antibiotics saving, Diagnosis, Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized strategy | Experimental | Procedure: Personalized antibiotic treatmentPersonalized 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). |
| Usual strategy | Other | Other: Usual antibiotic treatmentUsual antibiotic treatment Left at the discretion of the physician as in usual practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized antibiotic treatmentPersonalized antibiotic treatment based on mPCR results, PCT (values and kinetics) and appearance of sputum. | Procedure or surgery | Personalized strategy |
| Usual antibiotic treatmentThe antimicrobial therapy is left at the discretion of the physicians, as in usual practice. | Other | Usual strategy |
Primary outcome
Number of antibiotic-free days
Time frame: Day 28
The number of days alive without antibiotics at Day 28.
12 secondary outcomes
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
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume VOIRIOT, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized antibiotic treatment and Usual antibiotic treatment in people with Acute Exacerbation of COPD, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume VOIRIOT, Professor (01 56 01 62 63, guillaume.voiriot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of antibiotic-free days (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.