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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France2 sites
  • CHU Nîmes

    Nîmes

  • Bichat hospital

    Paris

Other trials in France

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.

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 groups in NCT05657275
Study groupRoleWhat they receive
Intervention periodExperimentalPatient 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 periodNo interventionPatient 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.

  1. Total duration (in days) of pulmonary-targeted antibiotic therapy

    Measured: day 30

Secondary outcomes (8)
  1. Total duration of hospitalization (in days)

    Measured: day 30

  2. Proportion of patients who died within 30 days

    Measured: day 30

  3. Proportion of patients rehospitalized within 30 days

    Measured: day 30

  4. Proportion of patients hospitalized in a single room

    Measured: day 30

  5. Proportion of patients with initiation of pulmonary-targeted antibiotic treatment in the emergency department

    Measured: day 1

  6. Proportion of patients with discontinuation of pulmonary-targeted antibiotic treatment in the emergency department

    Measured: day 3

  7. Proportion of patients with initiation or discontinuation of pulmonary-targeted antibiotic treatment in medical wards or ICU.

    Measured: day 30

  8. 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.

  1. First posted20 Dec 2022
  2. Study start9 Jan 2023
  3. Primary completion13 May 2024
  4. Study completion11 Jun 2024

Resources

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)
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

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.

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