Multicenter study to evaluate the effect and safety of oral vancomycin compared with placebo in the prevention of relapse due to Clostridium difficile infection in patients treated with antibiotics administered systemically.

Phase 1

• Conditions: Patients at high risk of recurrence due to CDI who require hospitalization and who increase morbidity and mortality from new CDI.; MedDRA version: 20.0Level: LLTClassification code 10072994Term: Clostridium difficile infection recurrenceSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-002677-57-ES
• Lead Sponsor: Dra. Julia Origüen Sabater

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Age equal to or greater than 18 years.
2. History of infection by Clostrioides difficile (CDI) in the previous 90 days.
3. That requires hospital admission and the need to receive systemic antibiotic treatment (at least 1 day of treatment with at least 1 antimicrobial agent during said admission).
4. Signature of informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Woman of childbearing age (less than 50 years old, except for those who present a gynecological report proving the presence of menopause) and women who are breastfeeding.
2. Allergy to vancomycin
3. Impossibility of complying with the study protocol, including the inability to ingest the capsules or to carry out adequate follow-up, including telephone follow-up or the possibility of transfer to the hospital in less than 48 hours if required.
4. State of extreme severity or life expectancy of less than 30 days.
5. Diagnosis of inflammatory bowel disease or other disease that conditions chronic diarrhea.
6. Criteria for diarrhea (3 or more liquid stools in the last 24 hours) or other clinical and / or microbiological data suggesting CDI at the time of selection or in the previous 3 days.
7. Antibiotic treatment concomitant or within the previous 5 days with oral vancomycin or other drugs active against C. difficile such as metronidazole, fidaxomicin, tigecycline, fusidic acid, rifaximin or nitazoxanide.
8. Have received preventive treatment with oral vancomycin or another active drug against C. difficile in the context of systemic antibiotic therapy in the previous 90 days, including fecal material transplantation.
9. That the patient takes more than 72 hours of systemic antibiotic treatment. If at the time of randomization the patient has been on antibiotic treatment for a longer time, the patient will not be eligible for this study.
10. Simultaneous participation in another clinical trial using investigational drugs.
11. Expected systemic antibiotic therapy time greater than 4 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified