An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care
- Conditions
- Lower Resp Tract Infection
- Interventions
- Diagnostic Test: ProcalcitoninDiagnostic Test: UltraProDiagnostic Test: Blood samplingDiagnostic Test: Naso-pharyngeal swab and sputum culture
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 469
- 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
- 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
- Arm && Interventions
Group Intervention Description Procalcitonin Procalcitonin General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm. The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents. Procalcitonin Naso-pharyngeal swab and sputum culture General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm. The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents. Usual Care Naso-pharyngeal swab and sputum culture General practitioners randomly assigned to the usual care arm will be responsible to recruit patients fulfilling the inclusion criteria and will manage and treat these patients as they usually do. Only general practitioners who do not use procalcitonin and lung ultrasonography routinely will be included in the usual care arm. Naso-pharyngeal swabs as well as sputum culture will be performed to allow for microbiologic identification of aetiological agents. UltraPro UltraPro General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm. The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents. UltraPro Naso-pharyngeal swab and sputum culture General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm. The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents. Procalcitonin Blood sampling General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm. The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents. UltraPro Blood sampling General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm. The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
- 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 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
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
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Vaud, Switzerland