Clostridium Difficile Infection
Conditions
Keywords
vancomycin, Clostridium difficile, Clostridium difficile infection, Recurrent Clostridium difficile infection
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.
Interventions
DRUGOral Vancomycin
Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence
Sponsors
Renown Regional Medical Center
University of Nevada, Reno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 reported adverse events | During hospitalization or the 12 weeks after therapy | — |
| Mortality rate | 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 | — |
Countries
United States
Outcome results
None listed