Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202602828392253 Date of Registration: 26/02/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Understanding the molecular epidemiology of Clostridiodes difficile infections in Western Kenya
Official scientific title Molecular Epidemiology of hospital-onset Clostridiodes difficile infections and antimicrobial resistance in Western Kenya
Brief summary describing the background and objectives of the trial Globally, the gram-positive obligate anaerobic, spore-forming C. difficile is a leading cause of hospital and community acquired diarrhea with an ever rising mortality rate, disability-adjusted life years and resistance to several antibacterial agents. This study aims to i) determine the incidence of C. difficile infections in western Kenyan hospitals, ii) determine the molecular characteristics of C. difficile strains circulating in western Kenya, iii) characterize the antimicrobial susceptibility of the isolated C. difficile strains, iv) determine the patient and hospital-related factors associated with C. difficile infections risk and develop a preliminary standardized protocol for regional surveillance of C. difficile infections. A prospective design will be adopted in which patients aged 2 years and above with hospital-onset diarrhoea will be recruited in three study sites of western Kenya region for a period of 12 months. Collected stool samples will be cultured on selective media. The isolates will be presumptively identified by colony morphology and gram staining and confirmed by multiplex PCR assays for glutamate dehydrogenase (GDH), toxin A (tcdA), toxin B (tcdB) and the binary toxin (cdtA/cdtB) genes. Confirmed C. difficile isolates will subsequently be ribotyped sequenced and their drug susceptibility evaluated against a panel of antibacterial agents using E-strip. The hospital CDI incidence rate will be calculated as C. difficille infection cases per 10,000 hospital admissions and per 10,000 hospital patient days. Patient demographics, underlying diseases, antibiotic use in the last 30 days and 30-day outcomes will be collected using a standard validated form and their association with C. difficile infections risk calculated. The study will provide comprehensive molecular epidemiological and antimicrobial resistance (AMR) data on C. difficile infections in western Kenya, which will form the basis for developing effective preventive, control and treatment protocols aimed at reducing diarrheal disease burden in the study region and beyond.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) WeKCDI study
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Clostridiodes difficile infection
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/05/2026
Actual trial start date 01/06/2026
Anticipated date of last follow up 30/06/2027
Actual Last follow-up date 31/12/2027
Anticipated target sample size (number of participants) 470
Actual target sample size (number of participants) 470
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diagnosis and standard of care treatment As per the local hospital-specific C.difficile treatment guideline Follow up, up to 30 days, since the day of diagnosis The patients with diarrhea will be diagnosed using rapid tests for GDH, toxin A and B. Then treated with standard of care treatment as per the local hospital guidelines 470
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Consenting participants aged above 18 years. ii. Patients aged 7 to 18 years, who will give assent and whose parents or legal guardian is willing to give consent. iii. Patients aged ≥2 years and <7 years whose parents or legal guardian is willing to give consent. iv. Patients with diarrhoea onset ≥72 hours after admission to the hospital. v. Patients with ≥ 3 loose (liquid) stools in 24 hours. i. Children below two years. ii. Children in Care (orphanage, child protection institutions). iii. Patients receiving ionisation radiation. iv. Patients with diarrhoea onset < 72 hour after admission to the hospital. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/11/2025 Masinde Muliro university of Science and Technology institutional scientific and ethics review commitee
Ethics Committee Address
Street address City Postal code Country
Off Kakamega Webuye Road Kakamega 50100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure of C. difficile infection associated diarrhoea 30 days after the diagnosis of hospital-onset diarrhoea
Secondary Outcome Complications ileus, Pseudomebrenanous colitis 30 days after the diagnosis of hospital-onset diarrhoea
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jaramogi Oginga Odinga Teaching and Referral Hospital Located along Kisumu- Kakamega Road Kisumu 40100 Kenya
Kakamega County General Hospital off Kakamega Webuye Road Kakamega 50100 Kenya
Bungoma County Referral Hospital Moi Avenue Township Kanduyi Bungoma 50200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
GlaxoSmithKline Services Unlimited 79 New Oxford Street, London WC1A 1DG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Masinde Muliro University of Science and Technology Off Kakamega Webuye Road Kakamega 50100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr Francis Ochieng Nakuru Nairobi road Nakuru 20100 Kenya
Dr Benjamin Ochieng Kisumu Busia road Kisumu 40100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sammy Kimoloi kimoloi@mmust.ac.ke 00254718233445 off kakamega-webuye road
City Postal code Country Position/Affiliation
Kakamega 50100 Kenya Lecturer researcher MMUST
Role Name Email Phone Street address
Public Enquiries Francis Orata directorrel@mmust.ac.ke 00254716903672 Off Kakamega Webuye road
City Postal code Country Position/Affiliation
Kakamega 50100 Kenya Director Research Extension and Linkages Directorate
Role Name Email Phone Street address
Scientific Enquiries Sammy Kimoloi kimoloi@mmust.ac.ke 00254718233 Off Kakamega webuye Road
City Postal code Country Position/Affiliation
Kakamega 50100 Kenya Lecturer and Researcer MMUST
Role Name Email Phone Street address
Scientific Enquiries Francis Ochieng franciseochieng@gmail.com 00254724306212 Nakuru Nairobi Road
City Postal code Country Position/Affiliation
Nakuru 20100 Kenya Internal medicine specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant’s data that underlies the generated results, after deidentification will be shared. Additional, study protocol, statistical plan and analysis and consent forms will be availed. Data will be made available immediately following publication of the main findings to researchers who request in writing with, alongside a robust proposal for any reasonable purposes. The requesting individual should write a formal letter to the PI via email address: kimoloi@mmust.ac.ke Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years after publication of a research article, thereafter the data will be found in the university repository Written request letter and signed data access agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information