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The PIRATE project: a Point-of-care, Informatics-based Randomised, controlled trial for decreasing over-utilisation of Antibiotic Therapy in Elderly and comorbid populations

English title The PIRATE project: a Point-of-care, Informatics-based Randomised, controlled trial for decreasing over-utilisation of Antibiotic Therapy in Elderly and comorbid populations
Applicant Huttner Angela
Number 167359
Funding scheme NRP 74 Smarter Health Care
Research institution Service des Maladies Infectieuses Département de Médecine Interne Hôpital Cantonal - HUG
Institution of higher education University of Geneva - GE
Main discipline Infectious Diseases
Start/End 01.04.2017 - 31.03.2020
Approved amount 421'873.00
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All Disciplines (2)

Discipline
Infectious Diseases
Information Technology

Keywords (5)

antibiotic therapy; Gram-negative bacteraemia; chronic-care patients; antibiotic over-utilisation; point-of-care randomisation

Lay Summary (French)

Lead
If misused, antibiotics can have detrimental effects not only on the health of the patient concerned but also the entire population through the development of resistance. This study aims to determine the optimal duration of antibiotic therapy on the basis of data extracted from patients’ electronic health records.
Lay summary

Les traitements antibiotiques devraient être sélectionnés et conduits selon des critères fondés sur les preuves aux fins d’éviter les interventions superflues ou préjudiciables. Des études randomisées contrôlées au « point of care » et fondées sur les données des dossiers électroniques des patient-e-s peuvent contribuer à les renforcer. Elles sont plus efficaces et meilleur marché que les études randomisées contrôlées classiques, et contribuent en outre à l’instauration de systèmes auto-apprenants dans la santé. Le but de cette étude consiste à réaliser et à valider une étude randomisée au point of care en utilisant les données extraites des dossiers électroniques des patient-e-s. Eelle vise à déterminer la durée optimale d’un traitement antibiotique dans les infections bactériennes du système sanguin. Elle repose sur l’hypothèse qu’une réduction de la durée de traitement chez le patient ayant une bonne évolution avant randomisation n’a pas d’effet néfaste, et contribuera à ralentir l’augmentation de la résistance bactérienne contre les antibiotiques.L’étude prend en compte 500 patient-e-s atteints de septicémie à bacille gram négatif, recrutés sur deux ans dans trois hôpitaux. Les patient-e-s seront répartis aléatoirement en moyennant le dossier electronique  en trois groupes: un premier groupe traité aux antibiotiques durant 14 jours, un deuxième durant sept jours et un troisième selon un schéma individuel. Après 30 jours, l’efficacité du traitement à ces différentes durées ainsi que les éventuelles complications seront évaluées sur la base des données des dossiers électroniques des patient-e-s. Cette étude contribue à éviter l’utilisation peu judicieuse des antibiotiques et les effets néfastes qui en résultent. Il en découle un effet positif sur la santé des patient-e-s ainsi que des bénéfices économiques, à l’instar d’une réduction de la surutilisation des antibiotiques et de la durée d’hospitalisation.

Direct link to Lay Summary Last update: 24.02.2017

Responsible applicant and co-applicants

Employees

Project partner

Publications

Publication
PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia
Huttner Angela, Albrich Werner C, Bochud Pierre-Yves, Gayet-Ageron Angèle, Rossel Anne, Dach Elodie von, Harbarth Stephan, Kaiser Laurent (2017), PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia, in BMJ Open, 7(7), e017996-e017996.
Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients with Uncomplicted Gram-negative Bacteremia
von Dach Elodie, Albrich Werner, Brunel Anne-Sophie, Prendki Virginie, Cuvélier Clémence, Flury Domenica, Gayet-Ageron Angèle, Huttner Benedikt, Kohler Philipp, Lemmenmeier Eva, McCallin Shawna, Rossel Anne, Harbarth Stephan, Kaiser Laurent, Bochud Pierre-Yves, Huttner Angela, Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients with Uncomplicted Gram-negative Bacteremia, in JAMA, 323(21).

Collaboration

Group / person Country
Types of collaboration
Bioinformatics, Geneva University Hospitals Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
European Congress of Clinical Microbiology and Infectious Diseases 2020 Talk given at a conference Effect of C-Reactive Protein–Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia 20.04.2020 Paris, France Huttner Angela;
European Congress of Clinical Microbiology and Infectious Diseases 2020 Poster C-reactive protein patterns by age, sex and pathogen in patients with gram-negative bacteremia 19.04.2020 Paris, France Kaiser Laurent; Huttner Angela; Bochud Pierre-Yves; von Dach Elodie; Albrich Werner; McCallin Shawna; Flury Domenica; Harbarth Stephan Jürgen;
42nd Annual Swiss Infectious Diseases Symposium 2020 Talk given at a conference The PIRATE Project: Effect of C-Reactive Protein–Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia 19.03.2020 Bern, Switzerland Huttner Angela;
Schweizerische Gesellschaft für Allgemeine Innere Medizin - Kongress 2019 Talk given at a conference Determiner de maniere fiable la duree de la therapie antibiotique 21.11.2019 Bern, Switzerland Huttner Angela;
Infectious Disease Colloquium, Division of Infectious Diseases, HUG Talk given at a conference PIRATE Project: Preliminary results 19.11.2019 Geneva, Switzerland von Dach Elodie; Harbarth Stephan Jürgen; Huttner Angela; Kaiser Laurent;
European Congress of Clinical Microbiology and Infectious Diseases 2019 Poster The PIRATE Project: pathogens and resistance profiles in patients with gram-negative bloodstream infections 13.04.2019 Amsterdam, Netherlands Albrich Werner; Bochud Pierre-Yves; Flury Domenica; Huttner Angela; Kaiser Laurent; von Dach Elodie; McCallin Shawna; Harbarth Stephan Jürgen;
Infectious Diseases Colloquium, Division of Infectious Diseases, Basel University Hospital Talk given at a conference Paying it forward in medicine: learning healthcare systems and the PIRATE Project 12.10.2018 Basel, Switzerland Huttner Angela;
Internal Medicine Roundtable, Trois Chênes Hospital Individual talk Point-of-Care Randomiized Trials & The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized, controlled trial for decreasing over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia 05.06.2018 Geneva, Switzerland Huttner Angela;
Infectious Diseases Colloquium, Division of Infectious Diseases, KSSG Individual talk The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized, controlled trial for decreasing over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia 04.05.2017 St. Gall, Switzerland Huttner Angela; Albrich Werner;
The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized, controlled trial for decreasing over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia Individual talk Infectious Diseases Colloquium, Division of Infectious Diseases, CHUV 17.04.2017 Lausanne, Switzerland Bochud Pierre-Yves; Huttner Angela;
Infectious Diseases Colloquium, Division of Infectious Diseases Individual talk The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized, controlled trial for decreasing over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia 04.04.2017 Geneva, Switzerland von Dach Elodie; Kaiser Laurent; Huttner Angela; Harbarth Stephan Jürgen;
General surgery colloquium, HUG Individual talk The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized, controlled trial for decreasing over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia 03.04.2017 Geneva, Switzerland Huttner Angela; von Dach Elodie;


Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
Seminar Workshop 10.12.2018 Basel, Switzerland Huttner Angela;
8th Symposium of the Bavarian Government: Antimicrobial Resistance (Munich, Germany) Talk 06.12.2017 Munich, Germany Huttner Angela;


Abstract

Our best intentions for the patients of today may be harming the patients of tomorrow. Physicians in Switzerland are cognizant of the current level of resource waste, but are confronted daily by an unfortunate triad: sick individuals in need of immediate help, a relative wealth of diagnostic and therapeutic options, and only a meagre evidence base proving that many of these options are simply unnecessary for the patient at hand. New methods to strengthen this evidence base-efficiently and at low cost-are long overdue, given that traditional randomised controlled trials (RCT) are expensive, time-consuming, and often lack external validity. Uniquely positioned to compare approved treatments or diagnostic techniques toward which there is clinical equipoise, novel point-of-care trials use the electronic health record (EHR) already in place in the majority of healthcare systems to embed pragmatic RCT in the clinical setting, thus creating “learning healthcare systems” to benefit current and future patients. The use of the EHR facilitates participant recruitment and data collection, minimising study overhead and excessive follow-up visits for patients, and maximising generalisability. Clinical outcomes data from “real” patients, also retrievable from the EHR, can be analysed efficiently and fed back to healthcare providers to guide later management. We propose to conduct the first POC randomised controlled trial in Switzerland and thereby build a platform for further low-cost, methodologically rigorous POC trials. As a seminal prototype, and with a focus on conserving an endangered healthcare resource for an aging population, the trial proposed here will assess optimal durations of antibiotic therapy for Gram-negative bacteraemia, a frequent - and frequently life-threatening - infection in patients with chronic conditions. Patients with chronic illnesses rely most on antibiotics and, through no fault of their own, misuse them the most. While health services research clearly aims to optimize the prevention and treatment of illnesses in our aging population, its goal must also be to safeguard the precious, limited resource without which these individuals cannot safely undergo routine cardiovascular and joint-replacement surgeries, chemo- and other immunosuppressive therapy, and for whom common infections and minor injuries could once again become life-threatening.
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