Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Drug: Oral Vancomycin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No oral vancomycin
Experimental: Oral vancomycin 125 mg twice daily	Drug: Oral Vancomycin; Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence
Experimental: Oral vancomycin 125 mg daily	Drug: Oral Vancomycin; Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics	Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline; Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins; High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin	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	HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks	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
Mortality rate		During hospitalization or the 12 weeks after therapy

Collaborators and Investigators

• Sponsor: University of Nevada, Reno
• Collaborators: Renown Regional Medical Center
• Investigators: Principal Investigator: Lauren Zion, PharmD, Renown Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Clostridium difficile; vancomycin; Clostridium difficile infection; Recurrent Clostridium difficile infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 1129396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No