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

N/ACompletedNCT03191071

Centre Hospitalier Universitaire Vaudois469 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

469

Conditions

Lower Resp Tract Infection

Interventions

UltraProDIAGNOSTIC_TEST

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 .

ProcalcitoninDIAGNOSTIC_TEST

Procalcitonin will be measured using a rapid point-of-care test

Blood samplingDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

Proportion of patients prescribed an antibiotic in each arm

For each arm, we will assess the proportion of patient's prescribed an antibiotic following the consultation with the general practitioner. This will be done by recording the prescription decision of the general practitioner.

Time frame: Assessed at day 28 after baseline

Secondary Outcomes

Duration of the episode

Number of days, within the first 28 days after enrolment, during which the patient's daily activities (work or recreation) were restricted by the lower respiratory tract infection. This will be assessed by telephone follow-up consultations

Time frame: Assessed at day 28 after baseline

Clinical failure

Presence of symptoms of an ongoing or relapsing lower respiratory tract infection at 28 days after enrolment. This will be assessed by a telephone follow-up consultation.

Time frame: Day 7 after baseline

Number of medical visits

The incidence of supplementary medical visits for the episode of lower respiratory tract infection within 28 days of enrolment will be assessed by reporting from the general practitioners and telephone follow-up consultations

Time frame: Day 7 and Day 28 after baseline

Serious adverse outcome

Secondary hospitalisation or death of any cause or disease specific complications (lung abscess, empyema and acute respiratory distress), within 28 days of enrolment. Assessed by serious adverse event reporting, general practitioner reporting and telephone follow-up.

Time frame: During the first 28 days following baseline

Duration of algorithm completion

Median duration of time spent for the medical consultation, procalcitonin testing, lung ultrasound and total time spent in the practice. These will be assessed by the general practitioner by filling in a case report form at baseline.

Data from ClinicalTrials.gov

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