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

NCT05320068 | Completed Phase 3

• 1 other identifier: PREVAN-ICD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridioides Difficile Infection

Keywords

Vancomycin oral capsules

Outcome Measures

Primary Outcomes (1)

• Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile

  Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.

  60 days after the beginning of the intervention

Secondary Outcomes (4)

• Effectiveness of treatment with oral vancomycin according to the number of previous recurrences

  60 days after the beginning of the intervention

• Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence

  60 days after the beginning of the intervention

• Effectiveness of treatment with oral vancomycin depending on antibiotic therapy

  60 days after the beginning of the intervention

• Tolerance and safety of treatment with oral vancomycin

  60 days after the beginning of the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.

Drug: Oral Vancomycin

Placebo group

PLACEBO COMPARATOR

A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.

Drug: Placebo

Interventions

Oral Vancomycin DRUG

A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.

Intervention group

Placebo DRUG

A blinded capsule that contains no vancomycin every 6 hours during 10 days.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Julia Orígüen: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Rafael San Juan

Madrid, Madrid, 28032, Spain

Location

Related Publications (31)

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MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• RAFAEL SAN-JUAN

  HOSPITAL 12 DE OCTUBRE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Julia Origüen Sabater, MD, PhD, Principal Investigator.

Model Details: Proportion 2:1 in favour to the intervention arm

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 11, 2022
• Study Start: August 2, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data generated by the research will be made available as soon as possible, wherever legally and ethically possible. It is Planned to share data starting 9 months after publication, and data will be available for 24 months thereafter.
• Access Criteria: IPD will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to rafael.san@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ES (1)