Urinary Tract Infections (UTIs)CAST-UTINCT07012421
Community Antibiotic Use, Susceptibility and ResisTance Among Patients With Urinary Tract Infections (CAST-UTI)
An observational study of Urinary Tract Infections (UTIs), run by St George's, University of London at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections (UTIs)
- How many people
- 890 participants
- Where
- 1 siteUganda
- Study dates
- 6 Oct 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- People without symptoms of UTI.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Infectious Diseases Research Collaboration (IDRC), Uganda
Kampala, Central Region, PO Box 7475
About this study
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)
- 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.
- Specific objectives
2-1 Primary objectives:
Read more
- 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.
- Conditions
- Urinary Tract Infections (UTIs)
- Keywords
- Low- and middle-income countries, Uganda, antibiotic resistance, urinary tract infection, multidrug resistant organisms
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of resistance profiles between GLASS and community uropathogens in Uganda
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).
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Patient pathway and antibiotic use in the community
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.
Measured: 28 days
Appropriateness of antimicrobial use in the treatment
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.
Measured: 7 days after enrolment
Retail outlet determinants of treating healthcare-seeking among patients with suspected UTIs
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.
Measured: through study completion, an average of 1 year
Antibiotic residues and AMR in two neighbourhoods in Kampala
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.
Measured: through study completion, an average of 1 year
Comparison of the diagnostic accuracy and usability of 'Utilizer ID' to Gold Standard microbiology, culture and sensitivity
Determination of the accuracy of the UTIlizer test with a comparison of positive, negative predictive values, sensitivity and specificity of the test
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start6 Oct 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infections (UTIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Infectious Diseases Research Collaboration, Uganda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012421
- Sponsor's protocol ID
- 2024.0149
- Other IDs
- 226461/Z/22/Z
- Acronym
- CAST-UTI
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD would contain identifiable personal information. Therefore, the anonymised data will be collected through REDCap which is a secure data management tool.
Publications
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.
PubMed 31703645Flores-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.
PubMed 25853778Cambaco 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.
PubMed 32727445Mbonye 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.
PubMed 26980439Frost 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.
PubMed 33845163Collignon 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.
PubMed 30700019Collignon 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.
PubMed 31261988Antimicrobial 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.
PubMed 35065702
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07012421
- Acronym / sponsor ID
- CAST-UTI / 2024.0149
- Conditions
- Urinary Tract Infections (UTIs)
- Keywords
- Low- and middle-income countries, Uganda, antibiotic resistance, urinary tract infection, multidrug resistant organisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Makerere University, Infectious Diseases Research Collaboration, Uganda
- Study start
- 6 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- People without symptoms of UTI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
Patient pathway and antibiotic use in the community
Time frame: 28 days
Appropriateness of antimicrobial use in the treatment
Time frame: 7 days after enrolment
Retail outlet determinants of treating healthcare-seeking among patients with suspected UTIs
Time frame: through study completion, an average of 1 year
Antibiotic residues and AMR in two neighbourhoods in Kampala
Time frame: through study completion, an average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 31703645Gebremariam 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.
- Background: PubMed 25853778Flores-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.
- Background: PubMed 32727445Cambaco 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.
- Background: PubMed 26980439Mbonye 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.
- Background: PubMed 33845163Frost 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.
- Background: PubMed 30700019Collignon 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.
- Background: PubMed 31261988Collignon 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.
- Background: PubMed 35065702Antimicrobial 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.
- Individual participant dataSharing planned: No. IPD would contain identifiable personal information. Therefore, the anonymised data will be collected through REDCap which is a secure data management tool.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections (UTIs), run by St George's, University of London at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of resistance profiles between GLASS and community uropathogens in Uganda (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012421, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.