Clinical trial

Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics

Name

1129396

Description

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Trial arms

Trial start

2018-03-08

Estimated PCD

2022-02-17

Trial end

2022-02-17

Status

Completed

Phase

Early phase I

Treatment

Oral Vancomycin

Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

Arms:

Oral vancomycin 125 mg daily, Oral vancomycin 125 mg twice daily

Size

104

Primary endpoint

Recurrent Clostridium difficile infection

During hospitalization or the 12 weeks after therapy

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years 2. Previous CDI diagnosis 3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics Exclusion Criteria: 1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome) 2. Previous adverse reactions to oral vancomycin 3. Requiring metronidazole during hospitalization 4. Known pregnancy 5. Expected survival \<72 hours 6. Patients receiving antibiotics only for surgical prophylaxis 7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

Updated at

2023-11-28

1 organization

1 product

1 indication

Organization

University of Nevada, Reno

Product

Vancomycin

Indication

Clostridium difficile infection