Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

Phase 4

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Oral Vancomycin

• Registration Number: NCT03466502
• Lead Sponsor: University of Nevada, Reno

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.

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 Timeline

• Study Start: 2018-03-08
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-15
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral vancomycin 125 mg twice daily	Oral Vancomycin	-
Oral vancomycin 125 mg daily	Oral Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Recurrent Clostridium difficile infection	During hospitalization or the 12 weeks after therapy	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

Secondary Outcome Measures

Name	Time	Method
Time between recurrent CDI and the last C diff infection	During hospitalization or the 12 weeks after therapy
Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics	During hospitalization or the 12 weeks after therapy	* 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
Rate of recurrence of CDI in immunocompromised patients	During hospitalization or the 12 weeks after therapy	HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks
Rate of reported adverse events	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
Mortality rate	During hospitalization or the 12 weeks after therapy

Trial Locations

Locations (1)

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States