Evidence map›Paper›PMID 38236365›Full record

Observational studyEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2024

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

Joachim Doua, Miquel Ekkelenkamp, Theo Verheij, Oscar Go, Stephen Ruhmel, Kimberly Leathers, Bart Spiessens, Sanne van Rooij, Vance G Fowler, Jeroen Geurtsen and 6 more

2 registry-linked trialsOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04087681 completednot on this map

Pilot Study to Assess Success Factors and Barriers for Preparation of a Phase 3 Study With ExPEC10V in Adults Aged 60 Years or Older and in Stable Health

TypeobservationalSponsorMJM BontenRan2019 to 2021Enrolled4,479ConditionsE.Coli Infections
NCT04899336 phase3completednot on this map

Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

TypeinterventionalSponsorJanssen Research & Development, LLCRan2021 to 2025Enrolled17,797ConditionsInvasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) PreventionArmsExPEC9V, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 4 countries.

Joachim DouaJanssen Research & Development, Beerse, Belgium.ORCID http://orcid.org/0000-0002-3503-3596
Miquel EkkelenkampDepartment of Medical Microbiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.ORCID http://orcid.org/0000-0001-5475-7875
Theo VerheijJulius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, the Netherlands.ORCID http://orcid.org/0000-0002-0166-1498
Oscar GoJanssen Research & Development, Raritan, NJ, USA.
Stephen RuhmelJanssen Research & Development, Titusville, NJ, USA.ORCID http://orcid.org/0000-0001-9682-3826
Kimberly LeathersDuke University School of Medicine, Durham, NC, USA.
Bart SpiessensJanssen Research & Development, Beerse, Belgium.
Sanne van RooijJulius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, the Netherlands.
Vance G FowlerDepartment of Medicine, Duke University Medical Center Durham, Durham, NC, USA.
Jeroen GeurtsenBacterial Vaccines Discovery and Early Development, Janssen Vaccines & Prevention B.V, Leiden, the Netherlands.
Rowena DolorDuke University School of Medicine, Durham, NC, USA.ORCID http://orcid.org/0000-0001-7317-9468
Michal SarneckiJanssen Vaccines, Branch of Cilag GmbH International, Bern, Switzerland. sarnecki.michal@gmail.com.ORCID http://orcid.org/0000-0001-7035-0020
Ranee ChatterjeeDuke University School of Medicine, Durham, NC, USA.ORCID http://orcid.org/0000-0002-4294-8081
Jan PoolmanBacterial Vaccines Discovery and Early Development, Janssen Vaccines & Prevention B.V, Leiden, the Netherlands.ORCID http://orcid.org/0000-0002-9583-8126
Marc BontenJulius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, the Netherlands.
on behalf COMBACTE-NET consortium/EXPECT study group
Utrecht University · NLDuke University · USHuman Vaccines Project Europe · NLJanssen (Belgium) · BEJanssen (United States) · USClinical Research Institute · USIQVIA (United States) · US

Funding

Innovative Medicines Initiative 115523
6 · The paper itself

Abstract

purposeInvasive 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).

methodsEXPECT-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.

resultsIn 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.

conclusionDeployment 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.

Indexed as

Escherichia coli InfectionsUrinary Tract InfectionsAgedEscherichia coliFeasibility StudiesHumansProspective StudiesBacterial infectionE. coliExtraintestinal pathogenic Escherichia coliInvasive Escherichia coli diseaseUrinary tract infectionVaccine

Identifiers

PMID38236365
PMCPMC10917840
OpenAlexW4390975500

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.