Procalcitonin and Lung Ultrasonography Based Antibiotherapy in Patients With Lower Respiratory Tract Infection in Swiss Emergency Departments: Pragmatic Stepped-wedge Cluster-randomized Trial
Trial ID: NCT05463406
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-12-05
Completion date: 2025-06-11
Sponsor: Dr Boillat-Blanco Noemie
Collaborators: Cantonal Hospital of St. Gallen; University Hospital, Basel, Switzerland; Kantonsspital Baden; Hôpital Intercantonal de la Broye, Payerne, Switzerland; Réseau Hospitalier Neuchâtelois; Hôpital Riviera-Chablais, Vaud-Valais; Luzerner Kantonsspital; Cantonal Hosptal, Baselland; St. Claraspital AG
Conditions: Lower Respiratory Tract Infection
Interventions: The PLUS algorithm; Usual care
Locations: Cantonal hospital of Baden; University Hospital of Basel; Kantonsspital Baselland; Luzerner Kantonsspital; Réseau Hospitalier Neuchâtelois; Cantonal Hospital of St. Gallen; Centre hospitalier universitaire vaudois (CHUV); Hôpital Intercantonal de la Broye; Hôpital Riviera-Chablais
Countries: Switzerland; Switzerland; Switzerland; Switzerland; Switzerland; Switzerland; Switzerland; Switzerland; Switzerland
Enrollment: 1407
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Outcomes:
Safety outcome; Efficacy outcome