Lower Resp Tract Infection
Conditions
Keywords
pneumonia, procalcitonin, lung ultrasound, point of care testing, antibiotic prescription, respiratory pathogens, host biomarkers
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.
Interventions
DIAGNOSTIC_TESTUltraPro
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_TESTProcalcitonin
Procalcitonin will be measured using a rapid point-of-care test
DIAGNOSTIC_TESTBlood 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_TESTNaso-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.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized clustered pragmatic trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 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. |
Countries
Switzerland
Outcome results
None listed