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Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection at primary care level : pragmatic cluster randomized trial

English title Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection at primary care level : pragmatic cluster randomized trial
Applicant Boillat Blanco Noémie
Number 167133
Funding scheme NRP 72 Antimicrobial Resistance
Research institution Université de Lausanne Faculté de Médecine
Institution of higher education University of Lausanne - LA
Main discipline Internal Medicine
Start/End 01.03.2017 - 29.02.2020
Approved amount 447'648.00
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Keywords (13)

Pneumonia; Lung ultrasound; Procalcitonin; Bronchitis; Lower respiratory tract infection; Primary Care; Acute respiratory tract infection; General practioners; Biomarker; Point-of-care test; Chest X-ray; Antibiotic resistance; Antibiotic stewardship

Lay Summary (German)

Lead
Mit aktuellen Tests lässt sich in der Hausarztpraxis nicht exakt genug feststellen, ob eine Lungenentzündung vorliegt, die mit Antibiotika behandelt werden muss. Wir erhöhen die Präzision, indem wir zwei neue diagnostische Methoden mit einem Algorithmus kombinieren.
Lay summary

Zu oft verschreiben Hausärzte bei akuten Atemwegsinfektionen Antibiotika, weil sie nicht unterscheiden können zwischen einer bakteriellen Lungenentzündung und nicht-bakteriellen Infektionen. Um die Diagnostik zu verbessern, entwickeln wir ein Vorgehen, das einen Lungen-Ultraschall mit einem Procalcitonin-Test kombiniert, der zwischen bakteriellen und viralen Infekten differenzieren hilft. Da jedoch beide Methoden für sich genommen zu viele unsichere Diagnosen liefern, kombinieren wir ihre Resultate mit einem Algorithmus, um so die Präzision zu erhöhen. In unserer Studie wenden mehrere Hausärzte dieses System an, und wir vergleichen die Menge der von ihnen verschriebenen Antibiotika sowie ihre Therapieerfolge mit jenen einer Vergleichsgruppe, die es nicht anwendet.

Hintergrund
Akute Atemwegsinfektionen gehören zu den häufigsten Gründen, aus denen Ärzte unnötigerweise Antibiotika verschreiben. Der Verbrauch dieser Medikamente sollte auf diesem Gebiet reduziert werden.

Ziel
Unser Ziel ist es, eine kostengünstige, praktisch anwendbare Methode zu entwickeln, welche bei Patienten mit Atemwegsinfektionen präziser als bisher feststellt, ob eine Lungenentzündung vorliegt, die mit Antibiotika behandelt werden muss.

Bedeutung
Da unsere Methode nur ein kleines mobiles Ultraschallgerät und einen einfach zu handhabenden Schnelltest erfordert, eignet sie sich für unterschiedlichste Settings und könnte sehr schnell breitflächig eingesetzt werden. Vor diesem Hintergrund erheben wir bei den teilnehmenden Ärzten unserer Studie zudem die Kriterien, welche den Einsatz der Methode begünstigen oder eher verhindern.


Direct link to Lay Summary Last update: 05.12.2017

Lay Summary (French)

Lead
Les méthodes utilisées pour identifier les infections respiratoires nécessitant une antibiothérapie dans les cabinets des généralistes ne sont pas assez performantes. Nous augmentons le degré de précision en combinant deux nouveaux outils diagnostiques dans un algorithme.
Lay summary

Les généralistes prescrivent trop souvent des antibiotiques en cas d’infection respiratoire aiguë parce qu’ils ne peuvent pas faire la différence entre une pneumonie bactérienne et des infections non-bactériennes. Pour améliorer l’approche diagnostique, nous développons un procédé qui combine un ultrason pulmonaire et un test rapide pour la procalcitonine, qui aide à différencier les infections bactériennes et virales. Comme les deux méthodes prises séparément livrent un trop grand nombre de diagnostics incertains, nous combinons les résultats dans un algorithme pour augmenter la précision. Dans notre étude, plusieurs généralistes utilisent cette stratégie et nous comparons leur taux de prescription d’antibiotiques et leurs succès thérapeutiques avec ceux d’un groupe témoin qui ne l’applique pas. .

Contexte
Les infections respiratoires aiguës font partie des causes les plus fréquentes pour lesquelles des médecins prescrivent inutilement des antibiotiques. Il convient de réduire la consommation de tels médicaments dans ce domaine.

Objectif
Notre objectif est de mettre au point un outil pratique et peu coûteux qui permette de mieux identifier les pneumonies, qui doivent être traitées par antibiotiques, parmi les patients avec une infection respiratoire que les méthodes utilisées jusqu’à présent.

Importance
Comme cette stratégie diagnostique ne requiert qu’un petit appareil portable et des tests rapides faciles à réaliser, elle se prête à toutes sortes de contextes et pourrait être étendue à large échelle très rapidement. De plus, nous évaluons les critères qui favorisent ou au contraire entravent son utilisation auprès des médecins participant à notre étude.

Direct link to Lay Summary Last update: 05.12.2017

Lay Summary (English)

Lead
Current tests do not allow GPs to determine with sufficient accuracy whether a patient has pneumonia requiring antibiotic therapy. We are increasing the precision of diagnosis by combining two new diagnostic tests with an algorithm.
Lay summary

General practitioners too often prescribe antibiotics for acute respiratory tract infections because they cannot distinguish between bacterial pneumonia and non-bacterial infections. In order to improve diagnosis we are developing a procedure that combines ultrasound examination of the lungs with a procalcitonin test helping in differentiating between bacterial and viral infections. However, since each method on its own produces too many unreliable diagnoses, we are combining their results with an algorithm to increase diagnostic precision. In our study, several general practitioners are using this strategy, and we are comparing the amount of antibiotics they prescribe and the therapeutic outcomes with those of a comparator group who are not using the strategy.

Background
Acute respiratory tract infections are among the most frequent reasons for unnecessary prescription of antibiotics. Use of these medicines for these infections needs to be reduced.

Aim
Our aim is to develop a low-cost, practicable method capable of determining with greater precision than in the past which patients with respiratory tract infections have pneumonia that requires treatment with antibiotics.

Relevance
Since our method requires only a small mobile ultrasound and a rapid, easy-to-perform test, it is suitable for a wide variety of settings and could be widely deployed very rapidly. We are also asking the doctors taking part in our study about criteria which tend to favour or hinder the use of the method.


Direct link to Lay Summary Last update: 05.12.2017

Responsible applicant and co-applicants

Employees

Name Institute

Project partner

Collaboration

Group / person Country
Types of collaboration
Department of Ambulatory Care and Community Medicine of Lausanne Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Université de Berne Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Swiss Tropical and Public Health Institute, Basel Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Swiss Society for Infectious Diseases - Joint Annual Meeting 2018 Poster Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection at primary care level: a pilot implementation study. 13.09.2018 Interlaken, Switzerland Boillat Blanco Noémie; Lhopitallier Loïc;
Swiss Society for Microbiology - Annual Meeting 2018 Talk given at a conference Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection at primary care level: a pilot implementation study. 29.08.2018 Lausanne, Switzerland Lhopitallier Loïc;
Quadrimed - Réunion Mensuelle Poster Lower respiratory tract infections - management and current research projects 20.06.2018 Crans-Montana, Switzerland Lhopitallier Loïc;
NRP72 Annual meeting Talk given at a conference Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection at primary care level: a pilot implementation study. 17.04.2018 Nottwill, Switzerland Boillat Blanco Noémie; Lhopitallier Loïc;


Abstract

Study ObjectivesGeneral objectiveThe goal of the project is to decrease unnecessary antibiotic prescription in adult patients with lower respiratory tract infections (LRTIs) managed at primary care level in Switzerland, using a simple algorithm based on 2 point-of-care test (POCT) results.Primary objectiveTo compare the rate of antibiotic prescription (at baseline and during follow-up) in patients with LRTI managed using procalcitonin (PCT) and lung ultrasound results (UltraPro, intervention arm 1), PCT result only (intervention arm 2) and usual care (routine control arm). Secondary objectivesTo compare the clinical outcome of patients with LRTI managed using UltraPro, PCT only and usual care. To evaluate the acceptability and feasibility of the interventions through extensive identification of barriers and facilitators. To calculate and compare cost-effectiveness between arms.InterventionUse of a new diagnostic approach (UltraPro) based on the results of a host biomarker (procalcitonin) point-of-care test and a portable lung ultrasound to decide on antibiotic prescription among adults with lower respiratory tract infections (LRTIs) at primary care level.Study RationaleThe highest volume of antibiotic prescription occurs at primary care level and the main reason for clinicians to prescribe antibiotics is the presence of an acute respiratory tract infection (ARI), even if the origin is viral in most cases. At primary care level, it is particularly challenging for physicians to identify patients with pneumonia - those who most likely will benefit from an antibiotic therapy - among those with LRTI. There are no reliable clinical predictors able to identify with certainty patients with pneumonia and so, pneumonia diagnosis relies on the presence of a chest X-ray infiltrate. However, the use of chest X-ray has several limitations as it is not always available, it exposes the patient to radiation, it has limited sensitivity and specificity and a high inter-observer variability in its interpretation. Lung ultrasound has recently been shown to be highly effective in detecting pneumonia infiltrates with a higher sensitivity and specificity than X-ray.One strategy aiming at reducing antibiotic use in primary care is to guide prescription based on host biomarker. Procalcitonin (PCT) is a sensitive biomarker to differentiate between bacterial and viral infection. However, its relatively low specificity makes it a suboptimal tool particularly in setting with higher rate of viral infections, such as general practitioners (GPs) practices. Lung ultrasound, which can identify patients with pneumonia, might compensate for the lack of specificity of PCT. According to the results of a recent survey, 30% of Swiss GPs do have an ultrasound machine at their practice and this proportion will probably further increase in a near future due to the development of portable and affordable machines together with available short training courses.Study design, setting and populationThis study will have two distinct phases.The first phase will test the feasibility of the intervention (UltraPro) along a pilot study using a combination of quantitative and qualitative measurements. Following the setup of a lung ultrasound training curriculum for GPs, the practicality of the whole UltraPro algorithm will be evaluated at primary care level. GPs working at the Permanence PMU-Flon of Lausanne, a walk-in centre managed by the Policlinique Médicale Universitaire, will participate in the pilot study. The results will allow to improving and refining the study procedures of the second phase. The second phase will be a pragmatic cluster randomized controlled trial investigating the proportion of patients treated by antibiotics when managed with the new algorithm combining PCT and ultrasonography results (UltraPro arm), compared to that of patients managed with PCT only (PCT arm) or usual care (routine arm). To ensure that the clinical outcome of patients managed with the UltraPro algorithm and with PCT only is as good as that of usual care, the duration of the episode, the number of medical visits, and the rate of treatment failures or adverse outcome by day 28 will be compared between the 3 arms. To allow future implementation if UltraPro proves to be effective and safe, a precise feasibility and cost-effectiveness assessment will also be performed during this phase. The level of randomization will be GPs, who will be recruited in different regions of Switzerland regions (Bern, Zurich Lausanne) and randomly allocated to one of the three study arms. These three regions have been chosen because of the good collaboration with a strong network of GPs during previous studies, which ensures optimal feasibility of the study, as well as representativeness regarding differences in antibiotic prescription rates.14 GPs will attend 15 patients in each arm, which means that 210 patients per arm and a total of 630 patients will be included over a period of 15 months.Expected outcomeWe expect to decrease antibiotic prescription for LRTIs at GPs practice level by improving diagnostic tools for pneumonia. These tools are based on a POCT technology which allows decentralization of the laboratory analyses and radiologic examination to the GPs practices. It will allow a fast and efficient management of patients with LRTIs. In case of favorable results, a wide scale implementation of this intervention seams feasible as it uses simple and portable technologies. These new diagnostic tools will need to be implemented in a controlled frame and accompanied by clear recommendations on which patients should be tested or not.
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