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Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

NCT ID: NCT03466502

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2022-02-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No oral vancomycin

Group Type NO_INTERVENTION

No interventions assigned to this group

Oral vancomycin 125 mg twice daily

Group Type EXPERIMENTAL

Oral Vancomycin

Intervention Type DRUG

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

Oral vancomycin 125 mg daily

Group Type EXPERIMENTAL

Oral Vancomycin

Intervention Type DRUG

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

Interventions

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Oral Vancomycin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renown Regional Medical Center

OTHER

Sponsor Role collaborator

University of Nevada, Reno

OTHER

Sponsor Role lead

Responsible Party

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Lauren Zion, PharmD

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauren Zion, PharmD

Role: PRINCIPAL_INVESTIGATOR

Renown Regional Medical Center

Locations

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Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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1129396

Identifier Type: -

Identifier Source: org_study_id