Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

Sponsor

University of Nevada, Reno (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03466502

Collaborator

Renown Regional Medical Center (Other)

104

Enrollment

Location

Arms

35.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Study Design

Study Type:

Interventional

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 :

Mar 8, 2018

Anticipated Primary Completion Date :

Feb 13, 2021

Anticipated Study Completion Date :

Feb 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

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

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

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
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]
HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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