Community-acquired PneumoniaPROMCAPNCT05657275
Impact on the Use of Antibiotics of a Multimodal Algorithm for the Diagnosis and Management of Acute Community-acquired Pneumonia in the Emergency Room
A study testing CRP dosage, multiplex PCR and chest scan without injection in people with Community-acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Reducing antibiotics prescription is still to date, the main goal in low respiratory tract infections (LRTI). Several studies have shown conflicting results on the impact of multiplex PCR as a point of care tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- CRP dosage, multiplex PCR and chest scan without injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Jan 2023to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient 18 years or older
- Presence of at least one respiratory sign among the following: dyspnea, cough, expectoration, auscultatory abnormalities, chest pain;
- Presence of at least one general sign among the following: fever (T>38°C), hypothermia (T<35°C), myalgia, headache, asthenia;
- Oxygen-requiring patient defined by a saturation <95% or presenting a risk area among:
- Age > 65 years old
- Alcoholic and/or tobacco intoxication
Show all 29Show fewer
- Congestive heart failure
- Cerebrovascular disease (stroke or transient ischemic attack)
- Chronic kidney disease (excluding dialysis)
- Chronic liver disease
- Unbalanced diabetes mellitus
- Progressive neoplastic disease
- Immunodepression (systemic corticosteroid therapy or immunosuppressive treatment within 6 months, splenectomy, chemotherapy within 6 months, HIV at the AIDS stage, cachexia, etc.)
- Homozygous sickle cell disease
- Bacterial pneumonia
- Hospitalization during the year
- Institutional life
- Non-inclusion Criteria:
- Patient unable to consent: coma or acute respiratory distress requiring orotracheal intubation
- Patient with chronic renal failure on dialysis
- Patient with a history of chronic obstructive pulmonary disease
- Lung transplant patient
- Patient being treated with antibiotics at the time of the emergency room consultation
- Patient simultaneously participating in an interventional study protocol (assessing the duration of antibiotic therapy)
- Pregnant or breastfeeding woman
- Patient refusal to participate
- Patient deprived of freedom or under a legal protective measure
- Patient under guardianship or curatorship or with cognitive impairment
- Non-affiliation to a social security regimen or CMU
Who cannot join
- RT-PCR positive for SARS-CoV-2
Trial locations and contacts
2 sites in 1 country.
About this study
Reducing antibiotics prescription is still to date, the main goal in low respiratory tract infections (LRTI).
Several studies have shown conflicting results on the impact of multiplex PCR as a point of care tool. Our experience has highlighted an impact on single room assignments during the winter season but not yet on antibiotics prescriptions. This project aims to evaluate a new multimodal algorithm including multiplex PCR at the point of care to reduce antibiotics prescription and therefore has the ability to have a positive impact on antibiotics resistance phenomenon.
Read the detailed description
Acute community-acquired pneumonia (CAP) is the leading infectious cause of infectious death worldwide and the third leading cause of death from all causes. They are also very frequent reasons for visit to the emergency room, especially during winter season. Although respiratory viruses are responsible for approximately 30 to 50% of CAP, antibiotics' prescription remain very high. This prescription is at the origin of the phenomenon of antibiotic resistance, which continues to increase throughout the world. In the meantime, the biological testing of this clinical picture is increasingly evolving since a decade, and this evolution has been even accelerated with the emergence of COVID-19. With regard to the increasing availability of respiratory viruses testing, we need more studies allowing to better use these results to spare antibiotics when useless.
Several avenues of study have been investigated to improve the diagnosis of bacterial CAP and thus reduce unnecessary antibiotic therapy: differentiating viral CAP from bacterial CAP using multiplex PCR and/or inflammation biomarkers, localizing the infection lung parenchyma using chest CT.
The various studies carried out on the impact of the use of multiplex PCR in the emergency department (ED) led to discordant conclusions. The study carried out within Bichat Claude-Bernard Hospital only shows an interest for single room assignment in patients infected with pathogens such as influenza, RSV and Metapneumovirus. Multiplex PCR delocalized to the ED does not seem to be a sufficient measure to reduce the prescription of antibiotics in patients suspected of CAP admitted from the emergency room. One study carried during the COVID-19 pandemic highlighted that multiplex PCR, used as a point of care, induced improvements in patient flow and infection control measures.
C Reactive Protein (CRP) is a well-known inflammation biomarker. Previous studies estimate that CRP has better performance than procalcitonin in the diagnosis of pneumonia with thresholds often described at 50 mg.L-1 and revised upwards in older patients. The National Institute for Health and Care Excellence (NICE) has endorsed the use of point-of-care CRP to diagnose CAP and reduce inappropriate antibiotic use. This recent meta-analysis suggests that CRP is a better marker than PCT for the diagnosis of pneumonia. Indeed, a CRP >20 mg/L, >50 mg/L or >100 mg/L has a positive LR+ likelihood ratio of 2.08, 3.68, and 5.79, respectively, and a negative LR- likelihood ratio of 0.32, 0.36, and 0.48, while PCT >0.25 µg/L or >0.50 µg/L has an LR+ of 5.43 and 8.25, respectively, and an LR- of 0.62 and 0.76.
In addition, the place of imaging in reducing the prescription of antibiotics in CAP is still very little studied; nevertheless, CT without injection has proven to be of great help in the diagnosis of COVID-19 and remains the gold standard (reference examination) for effectively diagnosing CAP.
The current recommendations of the French society of infectious diseases do not clearly mention the use of multiplex PCR. CRP is included as a biomarker of inflammation in favor of bacterial infection when it is high. The CT scan is mentioned in cases where the diagnosis of CAP is difficult without defining the criteria for this difficult diagnosis. The College of Pneumology Teachers updated in 2020 places multiplex PCR as an essential diagnostic tool in the management of CAP. Finally, the latest American recommendations (2018) mention the performance of a multiplex PCR as indicated in any patient admitted to hospital with symptoms of influenza-like illness. As a result, the practices of hospitals are very heterogeneous in the diagnosis of CAP, we therefore propose to develop a multimodal algorithm combining multiplex PCR, CRP and chest CT scan in the diagnosis of CAP in patients requiring hospitalization, starting as soon as possible during winter.
- Conditions
- Community-acquired Pneumonia
- Being tested
- CRP dosage, multiplex PCR, chest scan without injection
- Keywords
- CRP dosage, multiplex PCR, chest scan without injection
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP dosageDiagnostic test
multimodal algorithm
multiplex PCRDiagnostic test
multimodal algorithm
chest scan without injectionDiagnostic test
multimodal algorithm
| Study group | Role | What they receive |
|---|---|---|
| Intervention period | Experimental | Patient management will be guided by a multimodal algorithm integrating the performance of biological and iconographic examinations Receives: Diagnostic Test: CRP dosage; Diagnostic Test: multiplex PCR; Diagnostic Test: chest scan without injection |
| Control period | No intervention | Patient management will be done according to the usual practices of centers and emergency physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration (in days) of pulmonary-targeted antibiotic therapy
Measured: day 30
Secondary outcomes (8)
Total duration of hospitalization (in days)
Measured: day 30
Proportion of patients who died within 30 days
Measured: day 30
Proportion of patients rehospitalized within 30 days
Measured: day 30
Proportion of patients hospitalized in a single room
Measured: day 30
Proportion of patients with initiation of pulmonary-targeted antibiotic treatment in the emergency department
Measured: day 1
Proportion of patients with discontinuation of pulmonary-targeted antibiotic treatment in the emergency department
Measured: day 3
Proportion of patients with initiation or discontinuation of pulmonary-targeted antibiotic treatment in medical wards or ICU.
Measured: day 30
Proportion of patients with initiation of antiviral treatment
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start9 Jan 2023
- Primary completion13 May 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Chronological series in alternating periods, that is to say alternations of periods of more or less short duration, with and without intervention corresponding to a repetition of before/after studies will be carried
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- QIAGEN Gaithersburg, Inc
- Responsible party
- Sponsor
- Investigators
- Donia BOUZID, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657275
- Sponsor's protocol ID
- APHP221018
- Acronym
- PROMCAP
- Status last verified
- Oct 2024
- First submitted
- 10 Dec 2022
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Use of Antibiotics of a Multimodal Algorithm for the Diagnosis and Management of Acute Community-acquired Pneumonia in the Emergency Room
- ClinicalTrials.gov ID
- NCT05657275
- Acronym / sponsor ID
- PROMCAP / APHP221018
- Conditions
- Community-acquired Pneumonia
- Keywords
- CRP dosage, multiplex PCR, chest scan without injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- QIAGEN Gaithersburg, Inc
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 20 Dec 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.
Reducing antibiotics prescription is still to date, the main goal in low respiratory tract infections (LRTI).
Several studies have shown conflicting results on the impact of multiplex PCR as a point of care tool. Our experience has highlighted an impact on single room assignments during the winter season but not yet on antibiotics prescriptions. This project aims to evaluate a new multimodal algorithm including multiplex PCR at the point of care to reduce antibiotics prescription and therefore has the ability to have a positive impact on antibiotics resistance phenomenon.
Detailed description
Acute community-acquired pneumonia (CAP) is the leading infectious cause of infectious death worldwide and the third leading cause of death from all causes. They are also very frequent reasons for visit to the emergency room, especially during winter season. Although respiratory viruses are responsible for approximately 30 to 50% of CAP, antibiotics' prescription remain very high. This prescription is at the origin of the phenomenon of antibiotic resistance, which continues to increase throughout the world. In the meantime, the biological testing of this clinical picture is increasingly evolving since a decade, and this evolution has been even accelerated with the emergence of COVID-19. With regard to the increasing availability of respiratory viruses testing, we need more studies allowing to better use these results to spare antibiotics when useless.
Several avenues of study have been investigated to improve the diagnosis of bacterial CAP and thus reduce unnecessary antibiotic therapy: differentiating viral CAP from bacterial CAP using multiplex PCR and/or inflammation biomarkers, localizing the infection lung parenchyma using chest CT.
The various studies carried out on the impact of the use of multiplex PCR in the emergency department (ED) led to discordant conclusions. The study carried out within Bichat Claude-Bernard Hospital only shows an interest for single room assignment in patients infected with pathogens such as influenza, RSV and Metapneumovirus. Multiplex PCR delocalized to the ED does not seem to be a sufficient measure to reduce the prescription of antibiotics in patients suspected of CAP admitted from the emergency room. One study carried during the COVID-19 pandemic highlighted that multiplex PCR, used as a point of care, induced improvements in patient flow and infection control measures.
C Reactive Protein (CRP) is a well-known inflammation biomarker. Previous studies estimate that CRP has better performance than procalcitonin in the diagnosis of pneumonia with thresholds often described at 50 mg.L-1 and revised upwards in older patients. The National Institute for Health and Care Excellence (NICE) has endorsed the use of point-of-care CRP to diagnose CAP and reduce inappropriate antibiotic use. This recent meta-analysis suggests that CRP is a better marker than PCT for the diagnosis of pneumonia. Indeed, a CRP >20 mg/L, >50 mg/L or >100 mg/L has a positive LR+ likelihood ratio of 2.08, 3.68, and 5.79, respectively, and a negative LR- likelihood ratio of 0.32, 0.36, and 0.48, while PCT >0.25 µg/L or >0.50 µg/L has an LR+ of 5.43 and 8.25, respectively, and an LR- of 0.62 and 0.76.
In addition, the place of imaging in reducing the prescription of antibiotics in CAP is still very little studied; nevertheless, CT without injection has proven to be of great help in the diagnosis of COVID-19 and remains the gold standard (reference examination) for effectively diagnosing CAP.
The current recommendations of the French society of infectious diseases do not clearly mention the use of multiplex PCR. CRP is included as a biomarker of inflammation in favor of bacterial infection when it is high. The CT scan is mentioned in cases where the diagnosis of CAP is difficult without defining the criteria for this difficult diagnosis. The College of Pneumology Teachers updated in 2020 places multiplex PCR as an essential diagnostic tool in the management of CAP. Finally, the latest American recommendations (2018) mention the performance of a multiplex PCR as indicated in any patient admitted to hospital with symptoms of influenza-like illness. As a result, the practices of hospitals are very heterogeneous in the diagnosis of CAP, we therefore propose to develop a multimodal algorithm combining multiplex PCR, CRP and chest CT scan in the diagnosis of CAP in patients requiring hospitalization, starting as soon as possible during winter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Chronological series in alternating periods, that is to say alternations of periods of more or less short duration, with and without intervention corresponding to a repetition of before/after studies will be carried
| Arm | Type | Receives |
|---|---|---|
| Intervention period | Experimental | Diagnostic Test: CRP dosage, Diagnostic Test: multiplex PCR, Diagnostic Test: chest scan without injectionPatient management will be guided by a multimodal algorithm integrating the performance of biological and iconographic examinations |
| Control period | No intervention | –Patient management will be done according to the usual practices of centers and emergency physicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patient 18 years or older
- Presence of at least one respiratory sign among the following: dyspnea, cough, expectoration, auscultatory abnormalities, chest pain;
- Presence of at least one general sign among the following: fever (T>38°C), hypothermia (T<35°C), myalgia, headache, asthenia;
- Oxygen-requiring patient defined by a saturation <95% or presenting a risk area among:
- Patient unable to consent: coma or acute respiratory distress requiring orotracheal intubation
Key exclusion criteria (1 listed)
- RT-PCR positive for SARS-CoV-2
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 |
|---|---|---|
| CRP dosagemultimodal algorithm | Diagnostic test | Intervention period |
| multiplex PCRmultimodal algorithm | Diagnostic test | Intervention period |
| chest scan without injectionmultimodal algorithm | Diagnostic test | Intervention period |
Primary outcome
Total duration (in days) of pulmonary-targeted antibiotic therapy
Time frame: day 30
8 secondary outcomes
Total duration of hospitalization (in days)
Time frame: day 30
Proportion of patients who died within 30 days
Time frame: day 30
Proportion of patients rehospitalized within 30 days
Time frame: day 30
Proportion of patients hospitalized in a single room
Time frame: day 30
Proportion of patients with initiation of pulmonary-targeted antibiotic treatment in the emergency department
Time frame: day 1
Proportion of patients with discontinuation of pulmonary-targeted antibiotic treatment in the emergency department
Time frame: day 3
Proportion of patients with initiation or discontinuation of pulmonary-targeted antibiotic treatment in medical wards or ICU.
Time frame: day 30
Proportion of patients with initiation of antiviral treatment
Time frame: day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Donia BOUZID principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP dosage, multiplex PCR and chest scan without injection in people with Community-acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 29 inclusion and 1 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: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration (in days) of pulmonary-targeted antibiotic therapy (time frame: day 30). 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 16 Oct 2024.