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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UltraPro | Experimental | 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. |
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| Procalcitonin | Experimental | 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. |
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| Usual Care | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraPro | Diagnostic 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at day 28 after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at day 28 after baseline |
| Clinical failure |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noémie Boillat, PhD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1025 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37169498 | Derived | Geis D, Canova N, Lhopitallier L, Kronenberg A, Meuwly JY, Senn N, Mueller Y, Fasseur F, Boillat-Blanco N. Exploration of the Acceptance of the Use of Procalcitonin Point-of-Care Testing and Lung Ultrasonography by General Practitioners to Decide on Antibiotic Prescriptions for Lower Respiratory Infections: A Qualitative Study. BMJ Open. 2023 May 11;13(5):e063922. doi: 10.1136/bmjopen-2022-063922. | |
| 34548312 |
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Only coded and anonymous data will be made available to protect patients right to privacy
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 | Jun 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Randomized clustered pragmatic trial
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| Procalcitonin | Diagnostic Test | Procalcitonin will be measured using a rapid point-of-care test |
|
| Blood sampling | Diagnostic Test | 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. |
|
| Naso-pharyngeal swab and sputum culture | Diagnostic Test | 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. |
|
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. |
| 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 | 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. | 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. | Assessed at baseline (Day 0) |
| Satisfaction of providers | The overall satisfaction of general practitioners regarding the process of the consultation and its different components will be assessed using a Likert scale. | Assessed at baseline |
| Satisfaction of patients | 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. | Assessed at day 7 |
| Cost / effectiveness ratio | 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. | Assessed one month after data collection is complete |
| Aetiology of LRTIs in primary care | Prevalence of different respiratory pathogens as assessed by realtime multiplex PCR performed on a naso-pharyngeal swab and in sputum | Assessed within the first year after data collection is complete |
| Host biomarkers | Sensitivity and specificity of combinations of host biomarkers to identify patients with clinical failure or with pneumonia | Assessed within the first year after data collection is complete |
| Transcription patterns | Association between SNPs in genes involved in microvascular integrity and poor outcome or clinical failure | Assessed within the first year after data collection is complete |
| Derived |
| 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. |
| 31387559 | Derived | 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. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |