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Observational Study
. 2024 Mar;43(3):541-550.
doi: 10.1007/s10096-023-04738-y. Epub 2024 Jan 18.

Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study

Joachim Doua  1 , Miquel Ekkelenkamp  2 , Theo Verheij  3 , Oscar Go  4 , Stephen Ruhmel  5 , Kimberly Leathers  6 , Bart Spiessens  1 , Sanne van Rooij  3 , Vance G Fowler Jr  7   8 , Jeroen Geurtsen  9 , Rowena Dolor  6 , Michal Sarnecki  10   11 , Ranee Chatterjee  6 , Jan Poolman  9 , Marc Bonten  3 ; on behalf COMBACTE-NET consortium/EXPECT study group
Affiliations
Observational Study

Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study

Joachim Doua et al. Eur J Clin Microbiol Infect Dis. 2024 Mar.

Abstract

Purpose: Invasive Escherichia coli disease (IED) encompasses a diverse range of sterile site infections. This study evaluated the feasibility of capturing IED among community-dwelling older adults to inform the implementation of a phase 3 efficacy trial of a novel vaccine against IED (NCT04899336).

Methods: EXPECT-1 (NCT04087681) was a prospective, multinational, observational study conducted in medically stable participants aged ≥ 60 years. At least 50% of participants were selected based on a history of urinary tract infection (UTI) in the previous 10 years. The main outcomes were the incidence of IED and the number of hospitalisations reported by the site vs participant. The length of follow-up was 12 months. In a US-based substudy, a smartphone-based geofencing was evaluated to track hospital entries.

Results: In total, 4470 participants were enrolled (median age, 70.0 years); 59.5% (2657/4469) of participants had a history of UTI in the previous 10 years. Four IED events were captured through deployment of different tracking methods: a self-report, a general practitioner (GP) report, and a follow-up call. The incidence rate of IED was 98.6 events per 100,000 person-years. The number of reported hospitalisations was 2529/4470 (56.6%) by the site and 2177/4470 (48.7%) by participants; 13.8% of hospitalisations would have been missed if utilising only site reports. Geofencing detected 72 hospital entries.

Conclusion: Deployment of multiple tracking methods can optimise detection of IED among community-dwelling older adults. Older adults with a history of UTI could be feasibly targeted for a phase 3 vaccine efficacy trial through a network of GPs.

Keywords: E. coli; Bacterial infection; Extraintestinal pathogenic Escherichia coli; Invasive Escherichia coli disease; Urinary tract infection; Vaccine.

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Conflict of interest statement

Joachim Doua is an employee of Janssen Research & Development (a pharmaceutical company of Johnson & Johnson). Miquel Ekkelenkamp discloses that this project was funded by Innovative Medicines Initiative (IMI) of European Commission (hours declared on this project), COMBACTE-NET (grant agreement number 115523). Theo Verheij has no conflicts of interest to disclose. Oscar Go is an employee of Janssen Research & Development and owns equities. Stephen Ruhmel is an employee of Janssen Research & Development and owns stock and options in Johnson & Johnson. Kimberly Leathers has no conflicts of interest to disclose. Bart Spiessens was an employee of Janssen (a pharmaceutical company of Johnson & Johnson) at the time of the study and owns shares in Janssen. Sanne van Rooij has no conflicts of interest to disclose. Vance G. Fowler Jr discloses support for the present manuscript from the NIH; grants or contracts to his affiliated institution from the NIH, MedImmune, Allergan, Pfizer, Advanced Liquid Logics, Theravance, Novartis, Merck, Medical Biosurfaces, Locus, Affinergy, Contrafect, Karius, Genentech, Regeneron, Basilea, Janssen; royalties and licences from UpToDate; consulting fees from Novartis, Debiopharm, Genentech, Achaogen, Affinium, Medicines Co., MedImmune, Bayer, Basilea, Affinergy, Janssen, Contrafect, Regeneron, Destiny, Amphliphi Biosciences, Integrated Biotherapeutics, C3J, Armata, Valanbio, Akagera, Aridis, Roche, Pfizer; support by Contrafect for presenting phase 2 data at ECCMID 2019; a sepsis diagnostics patent; a role as an associate editor for Clinical Infectious Diseases between 2017–2022; and stock/stock options in ArcBio and ValanBio. Jeroen Geurtsen is an employee of Janssen Vaccines & Prevention (a pharmaceutical company of Johnson & Johnson) and owns stock options in Johnson & Johnson. Rowena Dolor discloses payments made to Duke University for this research project and a relationship with Universitair Medisch Centrum Utrecht. Michal Sarnecki is an employee of Janssen Vaccines, Branch of Cilag GmbH International Pharmaceutical (a pharmaceutical company of Johnson & Johnson) and owns unrestricted shares in Janssen Vaccines. Ranee Chatterjee has no conflicts of interest to disclose. Jan Poolman is an employee of Janssen Research & Development and owns stock options in Janssen Research & Development. Marc Bonten discloses grants or contracts paid to the University Medical Centre Utrecht (UMCU) by Janssen Vaccines, Novartis, CureVac and Merck; payment or honoraria to MJMB from Takeda; and payments to UMCU for participation on a data safety monitoring board or advisory board from Sanofi, Spherecydes, Pfizer, Merck, Novartis, and AstraZeneca.

Figures

Fig. 1
Fig. 1
Study flow diagram, Footnote: *One participant was enrolled and withdrew consent on the same day. This subject was classified as non-IED. IED invasive Escherichia coli disease
See this image and copyright information in PMC

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