Dataset Information

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

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.

SUBMITTER: Doua J

PROVIDER: S-EPMC10917840 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Doua Joachim J Ekkelenkamp Miquel M Verheij Theo T Go Oscar O Ruhmel Stephen S Leathers Kimberly K Spiessens Bart B van Rooij Sanne S Fowler Vance G VG Geurtsen Jeroen J Dolor Rowena R Sarnecki Michal M Chatterjee Ranee R Poolman Jan J Bonten Marc M

European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology 20240118 3

<h4>Purpose</h4>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).<h4>Methods</h4>EXPECT-1 (NCT04087681) was a prospective, multinational, observational study conducted in medically stable participants aged ≥ 60 years. At least 50% of participants were selecte ...[more]

PMID: 38236365

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Project description:Abstract Background A vaccine developed to prevent invasive extraintestinal pathogenic Escherichia coli disease (IED) is being evaluated in a phase 3 clinical trial (NCT04899336). However, historical performance of similar clinical trials has been challenged by inefficient endpoint catchment. Here we report the EXPECT-1 (NCT04087681) study findings on the capture techniques for IED and hospital admissions in a community-based setting. Methods EXPECT-1 was a prospective, observational study conducted in networks of 8 hospitals with surrounding primary care centers in North America, Europe, and Asia. Participants were followed for 1 year to track hospital admissions and occurrence of IED as reported by the primary care physician (PCP) or the participant. In 151 US participants, a geofence technology was used to track admissions to hospital areas. Participants were eligible if aged ≥ 60 years and if they did not have severe chronic conditions. Data were collected from October 24, 2019 until January 28, 2021. Study outcomes included incidence of IED and the rate of hospital admission. Results In total, 4470 participants were enrolled: 68% were female, 74.4% were white, median age was 70 years, and 59.4% had a urinary tract infection (UTI) in the past 10 years. Four IED events were captured with a cumulative incidence (95% CI) of 0.09% (0.024–0.229%) and an incidence rate of 98.6 cases (25.6–248.4) per 100,000 person-years. The incidence increased to 0.15% (0.041–0.385%) and 164.4 (43.8–420) per 100,000 person-years among participants with a history of UTI. Of the 4 IED events, 2 were participant self-reports, 1 PCP report, and 1 report via follow-up phone call. Of all hospital admissions, 56.6% were captured by PCPs and 48.7% by participants’ self-reports. The Kappa statistic varied from 0.31–0.65, indicating fair to moderate agreement between PCP reports and participant self-reports. Geofencing captured 99% of > 800 entries and exits from hospital areas. Conclusion The findings suggest that older adults with a history of UTI in the past 10 years may be a good target population for an efficacy clinical investigation on IED. PCP reports, participant self-reports, and geofencing can be promoted to track study endpoints in a community-based clinical trial setting. Disclosures Joachim Doua, MD, MPH, Janssen: Employee|Janssen: Stocks/Bonds Stephen Ruhmel, MPH, Janssen: Employee Oscar Go, PhD, Janssen: Employee of Janssen Research & Development LLC. Ranee Chatterjee, MD, MPH, Bristol Myers Squibb: Grant/Research Support|Epigenomics: Grant/Research Support|Verily: Grant/Research Support Michal Sarnecki, MD, Janssen: Employee|Janssen: Stocks/Bonds Jan Poolman, PhD, Janssen: Janssen Vaccines & Prevention B.V.|Janssen: Stocks/Bonds Marc Bonten, MD, PhD, Astra-Zeneca: Advisor/Consultant|Janssen: Advisor/Consultant|Merck: Advisor/Consultant|Novartis: Advisor/Consultant.

Project description:BackgroundCommunity acquired bacteremia (CAB) is a common cause of sepsis in low and middle-income countries (LMICs). However, knowledge about factors associated with outcomes of CAB in LMICs is limited.Methodology/principal findingsA prospective observational study (Ubon-sepsis) of adults admitted to a referral hospital with community-acquired infection in Northeastern Thailand was conducted between March 1, 2013 and February 1, 2017. In the present analysis, patients with a blood culture collected within 24 hours of admission that was positive for one of the three most common pathogens were studied. Clinical features, management, and outcomes of patients with each cause of CAB were compared. Of 3,806 patients presenting with community-acquired sepsis, 155, 131 and 37 patients had a blood culture positive for Escherichia coli, Burkholderia pseudomallei and Staphylococcus aureus, respectively. Of these 323 CAB patients, 284 (89%) were transferred from other hospitals. 28-day mortality was highest in patients with B. pseudomallei bactaeremia (66%), followed by those with S. aureus bacteraemia (43%) and E. coli (19%) bacteraemia. In the multivariable Cox proportional hazards model adjusted for age, sex, transfer from another hospital, empirical antibiotics prior to or during the transfer, and presence of organ dysfunction on admission, B. pseudomallei (aHR 3.78; 95%CI 2.31-6.21) and S. aureus (aHR 2.72; 95%CI 1.40-5.28) bacteraemias were associated with higher mortality compared to E. coli bacteraemia. Receiving empirical antibiotics recommended for CAB caused by the etiologic organism prior to or during transfer was associated with survival (aHR 0.58; 95%CI 0.38-0.88).Conclusions/significanceMortality of patients with CAB caused by B. pseudomallei was higher than those caused by S. aureus and E. coli, even after adjusting for presence of organ dysfunction on admission and effectiveness of empirical antibiotics received. Improving algorithms or rapid diagnostic tests to guide early empirical antibiotic may be key to improving CAB outcomes in LMICs.

Project description:BackgroundCircadian disturbances are commonly seen in people with Alzheimer's disease and have been reported in individuals without symptoms of dementia but with Alzheimer's pathology. We aimed to assess the temporal relationship between circadian disturbances and Alzheimer's progression.MethodsWe did a prospective cohort study of 1401 healthy older adults (aged >59 years) enrolled in the Rush Memory and Aging Project (Rush University Medical Center, Chicago, IL, USA) who had been followed up for up to 15 years. Participants underwent annual assessments of cognition (with a battery of 21 cognitive performance tests) and motor activities (with actigraphy). Four measures were extracted from actigraphy to quantify daily and circadian rhythmicity, which were amplitude of 24-h activity rhythm, acrophase (representing peak activity time), interdaily stability of 24-h activity rhythm, and intradaily variability for hourly fragmentation of activity rhythm. We used Cox proportional hazards models and logistic regressions to assess whether circadian disturbances predict an increased risk of incident Alzheimer's dementia and conversion of mild cognitive impairment to Alzheimer's dementia. We used linear mixed-effects models to investigate how circadian rhythms changed longitudinally and how the change integrated to Alzheimer's progression.FindingsParticipants had a median age of 81·8 (IQR 76·3-85·7) years. Risk of developing Alzheimer's dementia was increased with lower amplitude (1 SD decrease, hazard ratio [HR] 1·39, 95% CI 1·19-1·62) and higher intradaily variability (1 SD increase, 1·22, 1·04-1·43). In participants with mild cognitive impairment, increased risk of Alzheimer's dementia was predicted by lower amplitude (1 SD decrease, HR 1·46, 95% CI 1·24-1·72), higher intradaily variability (1 SD increase, 1·36, 1·15-1·60), and lower interdaily stability (1 SD decrease, 1·21, 1·02-1·44). A faster transition to Alzheimer's dementia in participants with mild cognitive impairment was predicted by lower amplitude (1 SD decrease, odds ratio [OR] 2·08, 95% CI 1·53-2·93), increased intradaily variability (1 SD increase, 1·97, 1·43-2·79), and decreased interdaily stability (1 SD decrease, 1·35, 1·01-1·84). Circadian amplitude, acrophase, and interdaily stability progressively decreased over time, and intradaily variability progressively increased over time. Alzheimer's progression accelerated these aging effects by doubling or more than doubling the annual changes in these measures after the diagnosis of mild cognitive impairment, and further doubled them after the diagnosis of Alzheimer's dementia. The longitudinal change of global cognition positively correlated with the longitudinal changes in amplitude and interdaily stability and negatively correlated with the longitudinal change in intradaily variability.InterpretationOur results indicate a link between circadian dysregulation and Alzheimer's progression, implying either a bidirectional relation or shared common underlying pathophysiological mechanisms.FundingNational Institutes of Health, and the BrightFocus Foundation.

Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

Similar Datasets

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