Clostridioides Difficile Infection
Conditions
Keywords
Vancomycin oral capsules
Brief summary
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered previous CDI and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first CDI.
Detailed description
As secondary objectives the investigators intend to: * Evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by the number of previous recurrences. * Compare the severity of recurrences in both study groups. * Compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed. * Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance. * Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of ICD recurrences.
Interventions
DRUGOral Vancomycin
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
DRUGPlacebo
A blinded capsule that contains no vancomycin every 6 hours during 10 days.
Sponsors
Instituto de Salud Carlos III
Julia Orígüen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Proportion 2:1 in favour to the intervention arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age equal or superior to 18 years * Previous history of Clostridioides difficile infection in the 90 days before the study enrolment * Need for hospitalization and need of antibiotic therapy * Signature of informed consent
Exclusion criteria
* Woman of childbearing age, pregnant woman, or breastfeeding woman * Hypersensitivity to vancomycin * Inability to comply with study protocol * Critically ill condition or life expectancy less than 30 days * Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea * Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment for eligibility or in the previous 3 days * Therapy with oral vancomycin or any other agent with activity against C. difficile for \>48 hours in the previous 3 days;. * Prophylaxis with oral vancomycin or any other agent with activity against C. difficile within the 70 days before the assessment for eligibility * Systemic antibiotic therapy for 72 hours or more before the recruitment * Ongoing enrolment in another RCT evaluating the effectiveness of other drugs * Estimated use of systemic antibiotic therapy for more than 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile | 60 days after the beginning of the intervention | Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of treatment with oral vancomycin according to the number of previous recurrences | 60 days after the beginning of the intervention | The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by index CDI episode (first episode or recurrence) |
| Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence | 60 days after the beginning of the intervention | The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo |
| Effectiveness of treatment with oral vancomycin depending on antibiotic therapy | 60 days after the beginning of the intervention | The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by the type of systemic antibiotic therapy prescribed. |
| Tolerance and safety of treatment with oral vancomycin | 60 days after the beginning of the intervention | Rate of major adverse events and drug-related adverse events. |
Countries
Spain
Outcome results
None listed