ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing)

NCT06297837 | Active Not Recruiting

• 1 other identifier: LHS0205
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are:

• Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)?
• Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient? Participants in this study will not be receiving treatments. The study will involve: Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs. Assessing whether it can help save money and resources in the lab and pharmacy.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• The overall number of susceptible results per panel available at day 1

  The overall number of susceptible results per panel available at day 1

  2 years

Secondary Outcomes (7)

• The number of susceptible results per panel available for WHO AWaRe Access category agents at day 1

  2 years

• The number of susceptible results per panel for orally-administrable agents available at day 1

  2 years

• The number of susceptible results per panel for intravenously-administrable agents available at day 1

  2 years

• The proportion of panels with no results available for WHO AWaRe Access category agents at day 1

  2 years

• The proportion of panels with no susceptible results of any kind available at day 1

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a suspected Urinary Tract Infection

You may qualify if:

• o The specimens for which AST predictions \& recommendations will be made are urine specimens processed by LCL Microbiology laboratory taken from patients ≥ 18 years old in LUHFT and/or GP locations that grew organisms within the period of the study dataset; these are the only specimens for which AST results will be available to train and test ADAPT-AST. Predictions will be made for all urine specimen types, including mid-stream urines, catheter specimens of urine and nephrostomy urine.

You may not qualify if:

• Urine specimens processed by LCL that did not grow organisms within the period of the study dataset
• Urine specimens taken from patients \< 18 years old
• Predictions will be made for asymptomatic bacteriuria screening specimens in pregnant women who have had specimens sent from a GP, but not those which have been sent from Liverpool Womens' NHS Foundation Trust (LWfT) Predictions for non-bacterial organisms grown in urine (i.e., fungi) will not be made.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, North West, United Kingdom

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 7, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-11

Locations

GB (1)