Clinical trial NCT07012421: Community Antibiotic Use, Susceptibility and ResisTance Among Patients With Urinary Tract Infections (CAST-UTI)
Official 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infections (UTIs)
Keywords: Low- and middle-income countries
Uganda
antibiotic resistance
urinary tract infection
multidrug resistant organisms
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Infectious Diseases Research Collaboration, Uganda
First posted: 2025-06-10
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with acute UTIs arriving in CDROs/clinics and hospitals within the boundaries of the two study communities are eligible to enrol (Namuwongo informal settlement, Muyenga, and Bukasa neighbourhoods) during the 12-month study collection period.

Workers from CDROs and healthcare clinics/ hospital outpatient departments from the same two communities will be asked to complete the surveys.

Brief summary: 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 two neighbourhoods in Kampala.


Eligibility criteria: 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.

Primary outcomes:
measure: A comparison of resistance profiles between GLASS and community uropathogens in Uganda
timeFrame: At the end of 12 months data collection
Secondary outcomes:
measure: Patient pathway and antibiotic use in the community
timeFrame: 28 days
measure: Appropriateness of antimicrobial use in the treatment
timeFrame: 7 days after enrolment
measure: Retail outlet determinants of treating healthcare-seeking among patients with suspected UTIs
timeFrame: At the end of 12 months after enrolment
measure: Antibiotic residues and AMR in two neighbourhoods in Kampala
timeFrame: Once a month for 12 months after study commencement
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Research Collaboration (IDRC), Uganda
state: Central Region
Study officials:
References:
citation: Gebremariam G, Legese H, Woldu Y, Araya T, Hagos K, GebreyesusWasihun A. Bacteriological profile, risk factors and antimicrobial susceptibility patterns of symptomatic urinary tract infection among students of Mekelle University, northern Ethiopia. BMC Infect Dis. 2019 Nov 8;19(1):950. doi: 10.1186/s12879-019-4610-2.
citation: Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015 May;13(5):269-84. doi: 10.1038/nrmicro3432. Epub 2015 Apr 8.
citation: Cambaco O, Alonso Menendez Y, Kinsman J, Sigauque B, Wertheim H, Do N, Gyapong M, John-Langba J, Sevene E, Munguambe K. Community knowledge and practices regarding antibiotic use in rural Mozambique: where is the starting point for prevention of antibiotic resistance? BMC Public Health. 2020 Jul 29;20(1):1183. doi: 10.1186/s12889-020-09243-x.
citation: Mbonye AK, Buregyeya E, Rutebemberwa E, Clarke SE, Lal S, Hansen KS, Magnussen P, LaRussa P. Prescription for antibiotics at drug shops and strategies to improve quality of care and patient safety: a cross-sectional survey in the private sector in Uganda. BMJ Open. 2016 Mar 15;6(3):e010632. doi: 10.1136/bmjopen-2015-010632.
citation: Frost I, Kapoor G, Craig J, Liu D, Laxminarayan R. Status, challenges and gaps in antimicrobial resistance surveillance around the world. J Glob Antimicrob Resist. 2021 Jun;25:222-226. doi: 10.1016/j.jgar.2021.03.016. Epub 2021 Apr 15. No abstract available.
citation: Collignon PJ, McEwen SA. One Health-Its Importance in Helping to Better Control Antimicrobial Resistance. Trop Med Infect Dis. 2019 Jan 29;4(1):22. doi: 10.3390/tropicalmed4010022.
citation: Collignon P, Beggs JJ. Socioeconomic Enablers for Contagion: Factors Impelling the Antimicrobial Resistance Epidemic. Antibiotics (Basel). 2019 Jun 30;8(3):86. doi: 10.3390/antibiotics8030086.
citation: Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19.