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Oral vancomycin prophylaxis for Hospital-onset Clostridioides difficile infection in high risk patients admitted to Thammasat University Hospital

Oral vancomycin prophylaxis for Hospital-onset Clostridioides difficile infection in high risk patients admitted to Thammasat University Hospital

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250328002
Enrollment
134
Registered
2025-03-28
Start date
2024-04-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital-onset Clostridioides difficile infection in high risk patients of Thammasat hospital Clostridium Infections

Interventions

Patients in this group will receive vancomycin 125 mg orally once daily while hospitalized, starting from the day they begin systemic antibiotics and continuing for 5 days after discontinuation of ant
Experimental Drug,No Intervention No treatment
Vancomycin prophylaxis,Non vancomycin prophylaxis

Sponsors

Faculty of Medicine, Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients in the internal medicine department at Thammasat University Hospital who have been hospitalized for at least 4 days and have received systemic antibiotics, along with at least one of the following risk factors 1. Age 65 years and older 2. Recent hospitalization or stay in a care facility within the past 3 months 3. Immunocompromised conditions, such as AIDS with CD4 less than 200 or cancer undergoing chemotherapy 4. Use of immunosuppressive drugs, including Prednisolone at least 20 mg/day (for at least 14 days), TNF inhibitors, Rituximab, Anakinra (IL-1 antagonist), Toclizumab (IL-6 antagonist), Alemtuzumab, Cyclophosphamide, or 5FU 5. History of abdominal surgery 6. Diabetes or end-stage kidney disease 7. Previous Clostridioides difficile infection (CDI) 8. Organ transplant or stem cell transplant recipients

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent. 2. Currently experiencing Clostridioides difficile infection. 3. Receiving Metronidazole or oral vancomycin treatment for other indications. 4. Unable to take oral vancomycin. 5. Currently taking probiotics. 6. History of vancomycin allergy or contraindications to its use. 7. Pregnant. 8. Previously treated for Clostridioides difficile infection using alternative methods such as fecal transplantation or received CDI treatment within the past month. 9. Expected to be discharged within 48 hours after enrollment in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of hospital-onset Clostridioides difficile infection At 30 days after study enrollment Diagnosis based on at least 3 loose stools per day for at least 24 hours from hospital day 4, plus a positive GDH and toxin A/B or GDH positive with clinical diagnosis and treatment by a physician

Secondary

MeasureTime frame
VRE and CRE infection At 30 days after study enrollment VRE and CRE infections will be identified from positive clinical cultures (blood, urine, wound, respiratory) and defined by clinician judgment ( bloodstream infection, UTI, pneumonia, wound infection),overall in hospital mortality At 30 days after study enrollment Identify deaths from electronic medical records (EMR) or discharge summaries,Length of hospital stay Within admission Calculate total days hospitalized from admission and discharge date

Countries

Thailand

Contacts

Public ContactWorapong Treewarunyu

Thammasat University

poompoom0404@gmail.com029269794

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026