NCT03466502

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

March 8, 2018

Last Update Submit

November 27, 2023

Conditions

Clostridium Difficile Infection

Keywords

vancomycinClostridium difficileClostridium difficile infectionRecurrent Clostridium difficile infection

Outcome Measures

Primary Outcomes (1)

  • Recurrent Clostridium difficile infection

    Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff

    During hospitalization or the 12 weeks after therapy

Secondary Outcomes (6)

  • Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics

    During hospitalization or the 12 weeks after therapy

  • Time between recurrent CDI and the last C diff infection

    During hospitalization or the 12 weeks after therapy

  • Rate of recurrence of CDI in immunocompromised patients

    During hospitalization or the 12 weeks after therapy

  • Rate of recurrence of CDI in patients with a history of the NAP-1 strain

    During hospitalization or the 12 weeks after therapy

  • Rate of reported adverse events

    During hospitalization or the 12 weeks after therapy

  • +1 more secondary outcomes

Study Arms (3)

No oral vancomycin

NO INTERVENTION

Oral vancomycin 125 mg twice daily

EXPERIMENTAL
Drug: Oral Vancomycin

Oral vancomycin 125 mg daily

EXPERIMENTAL
Drug: Oral Vancomycin

Interventions

Oral VancomycinDRUG

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 dailyOral vancomycin 125 mg twice daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Previous CDI diagnosis
  • Current admission with a suspected or a confirmed bacterial infection requiring antibiotics

You may not qualify if:

  • Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
  • Previous adverse reactions to oral vancomycin
  • Requiring metronidazole during hospitalization
  • Known pregnancy
  • Expected survival \<72 hours
  • Patients receiving antibiotics only for surgical prophylaxis
  • Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Lauren Zion, PharmD

    Renown Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 15, 2018

Study Start

March 8, 2018

Primary Completion

February 17, 2022

Study Completion

February 17, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)