Clinical trial NCT05320068: Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
Official title: Phase III,randomized,double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.difficile Infection in Patients Under Treatment with Systemic Antibiotic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridioides Difficile Infection
Keywords: Vancomycin oral capsules
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2022-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proportion 2:1 in favour to the intervention arm
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
timeFrame: 60 days after the beginning of the intervention
Secondary outcomes:
measure: Effectiveness of treatment with oral vancomycin according to the number of previous recurrences
timeFrame: 60 days after the beginning of the intervention
measure: Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence
timeFrame: 60 days after the beginning of the intervention
measure: Effectiveness of treatment with oral vancomycin depending on antibiotic therapy
timeFrame: 60 days after the beginning of the intervention
measure: Tolerance and safety of treatment with oral vancomycin
timeFrame: 60 days after the beginning of the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Rafael San Juan
Study officials:
affiliation: HOSPITAL 12 DE OCTUBRE
name: RAFAEL SAN-JUAN
role: STUDY_CHAIR
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