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

NCT07012421 | Recruiting

• 2 other identifiers: 2024.0149226461/Z/22/Z
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Urinary Tract Infections (UTIs)

Keywords

Low- and middle-income countries; Uganda; antibiotic resistance; urinary tract infection; multidrug resistant organisms

Outcome Measures

Primary Outcomes (1)

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

  Twelve-month 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).

  At the end of 12 months data collection

Secondary Outcomes (4)

• Patient pathway and antibiotic use in the community

  28 days

• Appropriateness of antimicrobial use in the treatment

  7 days after enrolment

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

  At the end of 12 months after enrolment

• Antibiotic residues and AMR in two neighbourhoods in Kampala

  Once a month for 12 months after study commencement

Study Arms (2)

Namuwongo community

The Namuwongo informal settlement is located in the urban area of Kampala, Uganda. An estimated 70% of residents in the informal settlement routinely (within the last month) use antibiotics. Houses are overcrowded with residents paying to use public toilets. The investigators are recruiting from community drug retail outlets and the outpatient department of Kitsugu health centre located next to Namuwongo.

Muyenga community

The Muyenga and Bukasa neighbourhoods are also located in the urban area of Kampala, Uganda, but is more affluent than the Namuwongo informal settlement. Residents in Muyenga can afford more expensive treatments at community drug retail outlets (CDROs)/clinics. The investigators are recruiting from community drug retail outlets and the outpatient department of Naguru hospital located next to Muyenga and Bukasa neighbourhoods.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• People without symptoms of UTI.

Sponsors & Collaborators

• St George's, University of London: lead
• Makerere University: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator

Study Sites (1)

Infectious Diseases Research Collaboration (IDRC), Uganda

Kampala, Central Region, PO Box 7475, Uganda

RECRUITING

Related Publications (8)

• 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.

  PMID: 31703645 BACKGROUND

• 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.

  PMID: 25853778 BACKGROUND

• 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.

  PMID: 32727445 BACKGROUND

• 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.

  PMID: 26980439 BACKGROUND

• 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.

  PMID: 33845163 BACKGROUND

• 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.

  PMID: 30700019 BACKGROUND

• 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.

  PMID: 31261988 BACKGROUND

• 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.

  PMID: 35065702 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample and perianal swab

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

Central Study Contacts

Catrin E Moore, DPhil, MBA, MSc, BSc, FRSB, FI

CONTACT

+44 2087252823; camoore@sgul.ac.uk

Henry Kajumbula, PhD

CONTACT

+256 41 4530 020; henrykajumbula427@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: June 10, 2025
• Study Start: October 6, 2024
• Primary Completion: October 5, 2025
• Study Completion: April 30, 2026
• Last Updated: June 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)