Oral Vancomycin vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Julia Orígüen
• Collaborator: Instituto de Salud Carlos III
• Treatments: Vancomycin

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

• Patients allergic to vancomycin

• Impossibility of fulfilling the 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

• Patients that meet diarrhea criteria or that present a Clostridioides Difficile infection at the time of patient's recruitment or during the 3 days prior.

• Antibiotic therapy with oral vancomycin at the time of patient's selection or during the 3 days prior, or with any drug that is effective against Clostrioides Difficile.

• Antibiotic prophylaxis with oral vancomycin or with any drug that is effective against Clostrioides difficile during the 90 days before the recruitment.

• Systemic antibiotic therapy for 72 hours or more before the recruitment

• Enrolment in another clinical trial that evaluates other drugs' effectiveness

• Estimated use of systemic antibiotic therapy for more than 4 weeks