NCT03191071

An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care

Procalcitonin and Lung Ultrasonography Point-of-care Testing to Decide on Antibiotic Prescription in Patients With Lower Respiratory Tract Infection at Primary Care Level: Pragmatic Cluster Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 469 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is randomized clustered pragmatic trial whose objective is to decrease unnecessary antibiotic prescription in adult patients with lower respiratory tract infection managed at primary care level in Switzerland, using a simple algorithm based on 2 point of care test results

Detailed description

The study will have two distinct phases: The first phase will test the feasibility of the intervention (UltraPro) along a pilot study. Following the setup of a lung ultrasound training curriculum for general practitioners, the practicality of the whole UltraPro algorithm will be evaluated at primary care level. The second phase will be a pragmatic randomized three-arm intervention study using an algorithm based on the results of procalcitonin and lung ultrasound to manage patients with lower respiratory tract infections at primary care level. The procalcitonin-ultrasound algorithm will be compared to procalcitonin-guided management alone and usual care.

Conditions

• Lower Resp Tract Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	UltraPro	First, procalcitonin will be measured using a rapid point-of-care test. In case of elevated procalcitonin result (≥0.25 µg/L), a lung ultrasound will be performed to look for the presence of a lung infiltrate or consolidation suggesting the presence of community acquired pneumonia. A portable ultrasound machine with a convex probe, that will be provided to the general practitioner by the study, will be used. The lung ultrasound will be done following international evidence-based recommendations for point-of-care lung ultrasound using the basic eight-region sonographic technique and the criteria for positive scan and positive examination for the diagnosis of pneumonia .
DIAGNOSTIC_TEST	Procalcitonin	Procalcitonin will be measured using a rapid point-of-care test
DIAGNOSTIC_TEST	Blood sampling	A venous blood sample (17.5 mL) will be collected. Whole blood and plasma will be stored at - 80°C. Further analysis will be performed in order to identify novel biomarkers and gene transcription patterns that could predict the necessity of antibiotic prescription or the severity of disease.
DIAGNOSTIC_TEST	Naso-pharyngeal swab and sputum culture	A pooled nasal swab will be performed and sputum will be collected. Samples will be stored at -80°C. Further analysis of the naso-pharyngeal swab and cultures of sputum will be performed to identify by molecular techniques pathogens implicated in the clinical presentation.

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-04-10
• Completion: 2020-04-30
• First posted: 2017-06-19
• Last updated: 2020-07-17

Locations

1 site across 1 country: Switzerland