Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

• ClinicalTrials.gov Identifier: NCT03466502
• Recruitment Status: Active, not recruiting
• First Posted: March 15, 2018
• Last Update Posted: December 10, 2020
• Sponsor: University of Nevada, Reno
• Collaborator: Renown Regional Medical Center
• Information provided by (Responsible Party): Lauren Zion, PharmD, University of Nevada, Reno

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Clostridium Difficile Infection	Drug: Oral Vancomycin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics
• Actual Study Start Date: March 8, 2018
• Estimated Primary Completion Date: February 13, 2021
• Estimated Study Completion Date: February 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Recurrent Clostridium difficile infection [ Time Frame: 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 :

1. Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics [ Time Frame: 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
2. Time between recurrent CDI and the last C diff infection [ Time Frame: During hospitalization or the 12 weeks after therapy ]
3. Rate of recurrence of CDI in immunocompromised patients [ Time Frame: 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
4. Rate of recurrence of CDI in patients with a history of the NAP-1 strain [ Time Frame: During hospitalization or the 12 weeks after therapy ]
5. Rate of reported adverse events [ Time Frame: During hospitalization or the 12 weeks after therapy ]
6. Mortality rate [ Time Frame: During hospitalization or the 12 weeks after therapy ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Nevada

Renown Regional Medical Center

Reno, Nevada, United States, 89502

Sponsors and Collaborators

University of Nevada, Reno

Renown Regional Medical Center

Investigators

• Principal Investigator: Lauren Zion, PharmD; Renown Regional Medical Center

More Information

• Responsible Party: Lauren Zion, PharmD, Pharmacist, University of Nevada, Reno
• ClinicalTrials.gov Identifier: NCT03466502
• Other Study ID Numbers: 1129396
• First Posted: March 15, 2018
• Last Update Posted: December 10, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Lauren Zion, PharmD, University of Nevada, Reno:

vancomycin; Clostridium difficile; Clostridium difficile infection; Recurrent Clostridium difficile infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Clostridium Infections; Enterocolitis, Pseudomembranous; Disease Attributes; Pathologic Processes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Vancomycin; Anti-Bacterial Agents; Anti-Infective Agents