Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Oral Vancomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vancomycin, Clostridium difficile, Clostridium difficile infection, Recurrent Clostridium difficile infection