Procalcitonin and Lung Ultrasonography Guided Antibiotherapy in Emergency Departments

NCT05463406 | Completed

• 2 other identifiers: PLUS-IS-LESSSNSF 33IC30_201300
• Study Type: interventional
• Target: 1,407
• Locations: 1 country
• Sites: 9

Brief Summary

Acute respiratory infections are a common reason of attendance at emergency departments. It is also the main reason of unnecessary antibiotic prescription. Antibiotics save lives, but can also directly harm patients by causing antibiotic-associated adverse events. Antibiotic use is directly related to resistance, which is one of the major threats of our century. In addition, some microorganisms live in and on the human body and promote many aspects of our health. Antibiotic treatment can disturb those microorganisms and therefore have long-lasting negative effects on our health. Unfortunately, it is difficult to differentiate between viral infections, which usually heal spontaneously, and bacterial pneumonia, which needs antibiotics treatment. This is one of the reasons of this over-prescribing of antibiotics. This project aims to reduce widespread use of antibiotics in the emergency department through a new diagnostic strategy of bacterial pneumonia. This strategy includes sequential use of well-known techniques: a clinical score, lung ultrasound and finally a biomarker, procalcitonin. The latter tends to be higher in bacterial infections. The combination of these different tests improves the diagnostic process and allows improved use of targeted antibiotics, with the ultimate goal of better patient management. The study will compare the antibiotic prescription rate and the clinical course of patients managed using this new diagnostic approach with those managed as usual. The project will also evaluate the acceptability and feasibility of this strategy and its cost-effectiveness. These two aspects are essential for a wider implementation of this innovative diagnostic approach and decrease antibiotic resistance.

Conditions

Lower Respiratory Tract Infection

Keywords

pneumonia; lung ultrasonography; procalcitonin; clinical prediction score; antimicrobial stewardship

Outcome Measures

Primary Outcomes (2)

• Safety outcome

  Proportion of patients with clinical failure (defined as a composite of any of the following: death or secondary ICU admission or secondary admission to hospital or hospital re-admission after index hospital discharge or complications due to the LRTI \[empyema, lung abscess\])

  Day 28

• Efficacy outcome

  Proportion of patients prescribed an antibiotic in each intervention group between enrolment and day 28

  Day 28

Secondary Outcomes (9)

• Quality of life measured with the community-acquired pneumonia symptom questionnaire

  Day 7, Day 28, Day 90

• Hospitalisation

  Day 0 to Day 90

• Efficacy endpoint

  Day 90

• Antibiotic side effects and C. difficile infection

  Day 0 to Day 28

• Emergency department stay

  Day 0 to Day 28

Study Arms (2)

The PLUS algorithm

EXPERIMENTAL

The PLUS clinical management algorithm: EDs having switched to the intervention period (intervention group) will manage their patients using the PLUS algorithm. The PLUS algorithm starts with a validated pneumonia clinical prediction score (score of Van Vugt), followed by LUS. In case of positive results of any of these tests, PCT is measured to identify patients who will most likely benefit from antibiotics. A validated clinical severity score will ensure the safety of the intervention in those with discordant results (LUS consolidation and low PCT).

Other: The PLUS algorithm

Usual care

OTHER

Usual care: management as usual

Other: Usual care

Interventions

The PLUS algorithm OTHER

Combination of a clinical prediction score and LUS, and if needed PCT measurement

The PLUS algorithm

Usual care OTHER

Management as usual

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Patients aged 18 years or more
• Acute LRTI (acute illness, less than 21 days, with at least one lower respiratory tract symptom, i.e. cough, sputum, dyspnea, chest pain and no alternative explanation)
• At least one of the following clinical criteria:
• Focal abnormal auscultation (decreased breath sounds, crackles, bronchial breath sounds)
• Fever (documented temperature ≥ 38°C in the last 24 hours, including self-measured temperature ≥ 38°C)
• Tachypnea (respiratory rate ≥ 22/minute)
• Tachycardia (heart rate ≥ 100/minute)

You may not qualify if:

• Previous receipt of a quinolone, macrolide or ceftriaxone or, of more than one dose of any other antibiotic within 72h prior to enrolment (excepted prophylactic antibiotics or antibiotics given for urinary tract infection)
• Previous hospital stay in the last 14 days
• Cystic fibrosis
• Severe COPD (≥GOLD 3 or if not available, as a proxy: exacerbation treated with antibiotics during the last 6 months)
• Severe immunodeficiency (drug-induced neutropenia with \<500 neutrophils/mm3, HIV infection with CD4\<200 cells/mm3, solid organ or bone marrow transplant recipient, prednisone ≥ 20mg/day for \>28 days)
• Initial admission of the patient in the intensive care unit
• Microbiologically-documented SARS-CoV-2
• Incapacity of discernment

Sponsors & Collaborators

• Dr Boillat-Blanco Noemie: lead
• Cantonal Hospital of St. Gallen: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Kantonsspital Baden: collaborator
• Hôpital Intercantonal de la Broye, Payerne, Switzerland: collaborator
• Réseau Hospitalier Neuchâtelois: collaborator
• Hôpital Riviera-Chablais, Vaud-Valais: collaborator
• Luzerner Kantonsspital: collaborator
• Cantonal Hosptal, Baselland: collaborator
• St. Claraspital AG: collaborator

Study Sites (9)

Cantonal hospital of Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

University Hospital of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Kantonsspital Baselland

Liestal, Canton of Basel-City, 4410, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Réseau Hospitalier Neuchâtelois

Neuchâtel, Canton of Neuchâtel, 2000, Switzerland

Location

Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Hôpital Intercantonal de la Broye

Payerne, Canton of Vaud, 1530, Switzerland

Location

Hôpital Riviera-Chablais

Rennaz, Canton of Vaud, 1847, Switzerland

Location

Related Publications (4)

• Lamping DL, Schroter S, Marquis P, Marrel A, Duprat-Lomon I, Sagnier PP. The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia. Chest. 2002 Sep;122(3):920-9. doi: 10.1378/chest.122.3.920.

  PMID: 12226033 RESULT

• Lhopitallier L, Kronenberg A, Meuwly JY, Locatelli I, Mueller Y, Senn N, D'Acremont V, Boillat-Blanco N. Procalcitonin and lung ultrasonography point-of-care testing to determine antibiotic prescription in patients with lower respiratory tract infection in primary care: pragmatic cluster randomised trial. BMJ. 2021 Sep 21;374:n2132. doi: 10.1136/bmj.n2132.

  PMID: 34548312 RESULT

• Lhopitallier L, Kronenberg A, Meuwly JY, Locatelli I, Dubois J, Marti J, Mueller Y, Senn N, D'Acremont V, Boillat-Blanco N. Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection in primary care: protocol of a pragmatic cluster randomized trial. BMC Pulm Med. 2019 Aug 6;19(1):143. doi: 10.1186/s12890-019-0898-3.

  PMID: 31387559 RESULT

• Bessat C, Bingisser R, Schwendinger M, Bulaty T, Fournier Y, Della Santa V, Pfeil M, Schwab D, Leuppi JD, Geigy N, Steuer S, Roos F, Christ M, Sirova A, Espejo T, Riedel H, Atzl A, Napieralski F, Marti J, Cisco G, Foley RA, Schindler M, Hartley MA, Fayet A, Garcia E, Locatelli I, Albrich WC, Hugli O, Boillat-Blanco N; PLUS-IS-LESS study group. PLUS-IS-LESS project: Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments: study protocol for a pragmatic stepped-wedge cluster-randomized trial. Trials. 2024 Jan 25;25(1):86. doi: 10.1186/s13063-023-07795-y.

  PMID: 38273319 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor and National coordinating investigator

Model Details: Pragmatic stepped-wedge cluster-randomized controlled clinical trial investigating a new algorithm combining a clinical score, LUS and PCT results (The PLUS algorithm) for the management of LRTIs among adults in EDs. The unit of randomization will be the ED.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 19, 2022
• Study Start: December 5, 2022
• Primary Completion: March 15, 2025
• Study Completion: June 11, 2025
• Last Updated: April 24, 2026

Record last verified: 2025-04

Locations

CH (9)