Clinical trial NCT03191071: An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Resp Tract Infection
Keywords: pneumonia
procalcitonin
lung ultrasound
point of care testing
antibiotic prescription
respiratory pathogens
host biomarkers
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clustered pragmatic trial
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: All patients presenting to a participating GP's office for a consultation for an acute respiratory infection (ARI) will be screened for inclusion in the study

Inclusion Criteria:

* Informed Consent as documented by signature (Informed Consent Form)
* Patients aged 18 years or more
* No antibiotics prescribed for the current episode
* Acute cough of up to 21 days duration and at least one of the following symptom or sign:
* History of fever for more than 4 days
* dyspnoea
* tachypnoea (≥ 22 cycles per minutes)
* abnormal focal finding during auscultation

Exclusion Criteria:

* Previous prescription of antibiotics for the current episode
* Working diagnosis of acute sinusitis or a non-infective disorder
* Cystic fibrosis
* Previous episode of chronic obstructive pulmonary disease exacerbation treated with antibiotics during the last 6 months
* Known pregnancy
* Severe immunodeficiency (untreated HIV infection with CD4 count \< 200 cells/mm3, solid organ transplant receiver, neutropenia, treatment with corticosteroids with dose equivalent to 20 mg prednisone/day for \> 28
* Admission of the patient
* GP not available for performing study
* Patient unable to provide informed consent

Primary outcomes:
measure: Proportion of patients prescribed an antibiotic in each arm
timeFrame: Assessed at day 28 after baseline
Secondary outcomes:
measure: Duration of the episode
timeFrame: Assessed at day 28 after baseline
measure: Clinical failure
timeFrame: Day 7 after baseline
measure: Number of medical visits
timeFrame: Day 7 and Day 28 after baseline
measure: Serious adverse outcome
timeFrame: During the first 28 days following baseline
measure: Duration of algorithm completion
timeFrame: Assessed at baseline (Day 0)
measure: Satisfaction of providers
timeFrame: Assessed at baseline
measure: Satisfaction of patients
timeFrame: Assessed at day 7
measure: Cost / effectiveness ratio
timeFrame: Assessed one month after data collection is complete
measure: Aetiology of LRTIs in primary care
timeFrame: Assessed within the first year after data collection is complete
measure: Host biomarkers
timeFrame: Assessed within the first year after data collection is complete
measure: Transcription patterns
timeFrame: Assessed within the first year after data collection is complete
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Noémie Boillat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.