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Completed

NCT Number: NCT07012421

Community Antibiotic Use, Susceptibility and ResisTance Among Patients With Urinary Tract Infections (CAST-UTI)

1. General objective

This pilot study aims to compare the prevalence of resistance in bacteria causing UTIs among patients seeking care outside the hospital settings (CDROs) to the WHO-GLASS data. 2. Specific objectives

2-1 Primary objectives:

* Determine the resistance profiles of uropathogens and carriage strains from patients with uncomplicated UTIs attending community drug retail outlets (CDRO's) and in hospitals*. * Compare the resistance profiles of the uropathogens from patients with uncomplicated UTIs attending CDROs and hospitals to those in the WHO-GLASS database. * Explore the patient pathway and its impact on antibiotic use among patients presenting to CDROs and hospitals with uncomplicated UTIs. * Determine the appropriateness of antimicrobial use in the treatment of uncomplicated UTIs among patients presenting to CDROs and hospitals

2-2 Secondary objectives:

* Compare resistance profiles among the uropathogens from patients from two neighbourhoods in Kampala. * Examine environmental samples between the study sites to determine the presence of antibiotic residues and AMR in two neighbourhoods in Kampala.

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Key information

Conditions

Urinary Tract Infections (UTIs) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Infectious Diseases Research Collaboration (IDRC), Uganda

Kampala, Central Region, PO Box 7475, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have one or more of the following clinical presentations regardless of age:

acute (< 2 weeks) dysuria. increased urinary urgency and frequency, irritation, discharge. increased lower abdominal pain or discomfort and sometimes gross haematuria.

  • In elderly patients with pre-existing urinary symptoms: increased acute urinary changes.

Exclusion criteria

  • People without symptoms of UTI.

Treatment and study plan

Primary outcomes

  1. A comparison of resistance profiles between GLASS and community uropathogens in Uganda

    Time frame: through study completion, an average of 1 year

    Prevalence of antimicrobial resistance in Escherichia coli and Klebsiella pneumoniae isolates causing urinary tract infections, comparing GLASS surveillance data and data collected in the community in Uganda. Resistance will be measured as the proportion of isolates non-susceptible to key antibiotic classes (e.g., third-generation cephalosporins, fluoroquinolones, carbapenems).

Secondary outcomes

  1. Patient pathway and antibiotic use in the community

    Time frame: 28 days

    Characterisation of the patient pathway from symptom onset to days 7 and 28 in individuals with urinary tract infections, and its association with antibiotic use patterns (e.g., timing, type, source, appropriateness).

    Collect information on healthcare seeking behaviour for eligible patients, including their sociodemographic information, antibiotics purchased, and cost of antibiotics.

  2. Appropriateness of antimicrobial use in the treatment

    Time frame: 7 days after enrolment

    Proportion of UTI cases in the community with microbiologically confirmed E. coli or K. pneumoniae where the prescribed or obtained antibiotic treatment was appropriate, based on standard treatment guidelines and the organism's resistance profile.

  3. Retail outlet determinants of treating healthcare-seeking among patients with suspected UTIs

    Time frame: through study completion, an average of 1 year

    The investigators are collecting information on the number of UTIs presenting at community drug retail outlets over twelve months, antibiotic availability in the community drug retail outlet, compliance with regulations, and healthcare worker training level.

  4. Antibiotic residues and AMR in two neighbourhoods in Kampala

    Time frame: through study completion, an average of 1 year

    Detection of antibiotic residues and antimicrobial resistant organisms in environmental water samples from channels linking the two study neighbourhoods.

    Through detection of antibiotic residues and testing of microorganisms isolated from the waterway and soil in the surrounding areas.

  5. Comparison of the diagnostic accuracy and usability of 'Utilizer ID' to Gold Standard microbiology, culture and sensitivity

    Time frame: through study completion, an average of 1 year

    Determination of the accuracy of the UTIlizer test with a comparison of positive, negative predictive values, sensitivity and specificity of the test

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • Infectious Diseases Research Collaboration, Uganda
  • Makerere University

Registry information

Official study title

Comparison of Community and Hospital Antibiotic Use Practices, Susceptibility and ResisTance and Determinants of Care Seeking Among Patients With Urinary Tract Infections (CAST-UTI)

Acronym: CAST-UTI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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