To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With PneumoniaBPCTréa2NCT06301841
An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
A study testing experimental in people with To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia, run by University Hospital, Caen at 1 site in France.
Trial summary
Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia
- What is being tested?
- experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2024to 15 Jul 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
- Patients over 18 years
- Documented or suspected clinically COPD according to the criteria of GOLD
- Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
- Admitted to the hospital for less than 48 hours
- ICU Admission
- Informed Consent signed by the patient or his representative
Who cannot join
- Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection
- Therapeutic limitation Existence
- Minor patient or under guardianship or custody
- Pregnant woman
- Refusal to participate in the study
- The inclusion of the subject in another biomedical research protocol in progress or for less than 30 day
- Patients treated with antibiotics before ICU referral are no excluded.
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
Medical Intensive Care Unit, CHU Caen
Caen, 14000
Cédric Daubin, MD, daubin-c@chu-caen.fr
About this study
Official title: Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.
- Being tested
- experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalOther
At day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation.
Discontinuation is encouraged in case of no bacteria documentation and a procalcitonin < 1 ng/L; discontinuation is even encouraged if a viral documentation is concurrently obtained. In case of no bacteria documentation and a procalcitonin > 1 nd/L, antibiotic continuation is encouraged for additional two days.
In case of bacteria documentation, antibiotic continuation is encouraged, but with narrowing the spectrum as much as possible. The duration of antibiotics is based on a procalcitonin algorithm: procalcitonin < 0.1 nd/l: discontinuation; 0.1 ng/l < procalcitonin < 0.25 ng/l: additional 1 day; procalcitonin > 0.25 ng/l: additional 2 days.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Conventional microbiological investigations are performed as soon as possible after ICU admission including blood cultures, non-invasive or invasive respiratory tract sample, urine antigen assays and viral PCR. Antibiotics have to be started as soon as possible after ICU admission and during at less 3 days |
| Intervention | Experimental | In addition to conventional microbiological investigations, a non-invasive or invasive respiratory tract sample is collected as soon as possible and tested with the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux). This test detects 18 bacteria, 9 viruses and 7 antibiotic resistance markers. In addition a procalcitonin assay is performed on day-3 of ICU admission.
Antibiotics have to be started as soon as possible after ICU admission and during at less 3 days.
At day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation. Receives: Other: experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic therapy
The number of antibiotic-days for the treatment of pneumonia
Measured: from ICU admission to day 28 or hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start7 May 2024
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With PneumoniaStudies of the same condition, open and under way.
- 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cedric daubin, MD, Principal investigator, CHU de Caen Normandie, Médecine Intensive et Réanimation Médicale, 14000 CAEN, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301841
- Sponsor's protocol ID
- 2023-A00903-42
- Acronym
- BPCTréa2
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
- ClinicalTrials.gov ID
- NCT06301841
- Acronym / sponsor ID
- BPCTréa2 / 2023-A00903-42
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 8 Mar 2024 (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.
Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Conventional microbiological investigations are performed as soon as possible after ICU admission including blood cultures, non-invasive or invasive respiratory tract sample, urine antigen assays and viral PCR. Antibiotics have to be started as soon as possible after ICU admission and during at less 3 days |
| Intervention | Experimental | Other: experimentalIn addition to conventional microbiological investigations, a non-invasive or invasive respiratory tract sample is collected as soon as possible and tested with the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux). This test detects 18 bacteria, 9 viruses and 7 antibiotic resistance markers. In addition a procalcitonin assay is performed on day-3 of ICU admission. Antibiotics have to be started as soon as possible after ICU admission and during at less 3 days. At day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years
- Documented or suspected clinically COPD according to the criteria of GOLD
- Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
- Admitted to the hospital for less than 48 hours
- ICU Admission
Key exclusion criteria (7 listed)
- Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection
- Therapeutic limitation Existence
- Minor patient or under guardianship or custody
- Pregnant woman
- Refusal to participate in the study
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 |
|---|---|---|
| experimentalAt day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation. Discontinuation is encouraged in case of no bacteria documentation and a procalcitonin < 1 ng/L; discontinuation is even encouraged if a viral documentation is concurrently obtained. In case of no bacteria documentation and a procalcitonin > 1 nd/L, antibiotic continuation is encouraged for additional two days. In case of bacteria documentation, antibiotic continuation is encouraged, but with narrowing the spectrum as much as possible. The duration of antibiotics is based on a procalcitonin algorithm: procalcitonin < 0.1 nd/l: discontinuation; 0.1 ng/l < procalcitonin < 0.25 ng/l: additional 1 day; procalcitonin > 0.25 ng/l: additional 2 days. | Other | Intervention |
Primary outcome
Duration of antibiotic therapy
Time frame: from ICU admission to day 28 or hospital discharge
The number of antibiotic-days for the treatment of pneumonia
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 24 Jul 2025.
- Individual participant dataSharing planned: No
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.
cedric daubin, MD principal investigator
CHU de Caen Normandie, Médecine Intensive et Réanimation Médicale, 14000 CAEN, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental in people with To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia, run by University Hospital, Caen 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 6 inclusion and 7 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 24 Jul 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 cedric daubin, MD (33 2 31 06 47 16, daubin-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotic therapy (time frame: from ICU admission to day 28 or hospital discharge). 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 24 Jul 2025.