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

Not Applicable

Completed

• Conditions: Lower Resp Tract Infection

• Registration Number: NCT03191071
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Study Timeline

• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2018-09-01
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 469

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients prescribed an antibiotic in each arm	Assessed at day 28 after baseline	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.

Secondary Outcome Measures

Name	Time	Method
Serious adverse outcome	During the first 28 days following baseline	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.
Duration of algorithm completion	Assessed at baseline (Day 0)	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.
Aetiology of LRTIs in primary care	Assessed within the first year after data collection is complete	Prevalence of different respiratory pathogens as assessed by realtime multiplex PCR performed on a naso-pharyngeal swab and in sputum
Duration of the episode	Assessed at day 28 after baseline	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
Transcription patterns	Assessed within the first year after data collection is complete	Association between SNPs in genes involved in microvascular integrity and poor outcome or clinical failure
Satisfaction of providers	Assessed at baseline	The overall satisfaction of general practitioners regarding the process of the consultation and its different components will be assessed using a Likert scale.
Satisfaction of patients	Assessed at day 7	The overall satisfaction of patients regarding the process of the consultation and of follow-up will be assessed using a Likert scale. These will be assessed by telephone follow-up.
Clinical failure	Day 7 after baseline	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.
Cost / effectiveness ratio	Assessed one month after data collection is complete	Cost / effectiveness ratio expressed as the cost required per 1% decrease of the rate of antibiotic prescription during the studio will be assessed using review of the medical records and estimation of the costs of the various process of the diagnostic algorithm based on the Swiss Federal HealthCare Law.
Host biomarkers	Assessed within the first year after data collection is complete	Sensitivity and specificity of combinations of host biomarkers to identify patients with clinical failure or with pneumonia
Number of medical visits	Day 7 and Day 28 after baseline	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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland