Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
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|ClinicalTrials.gov Identifier: NCT02951702|
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : December 27, 2017
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Prophylaxis Vancomycin||Drug: Vancomycin Oral||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||July 2017|
No Intervention: Control
This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"
Experimental: Vancomycin Oral
This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Intervention type: drug, vancomycin 125 mg daily
Drug: Vancomycin Oral
This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Other Name: Oral vancomycin; vancomycin
- Clostridium Difficile Infection Occurrence [ Time Frame: Within 4 weeks from the completion of antibiotic treatment ]The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.
- Time to Clostridium Difficile Infection Occurence [ Time Frame: Within 4 weeks from completion of antibiotic treatment ]This is the time from the start of antibiotics to the diagnosis of clostridium difficile.
- Clostridium Difficile Infection Severity [ Time Frame: Within 4 weeks from completion of antibiotic treatment ]Severity as defined by the IDSA/SHEA guidelines (mild to moderate, defined as white-cell count less than 15,000 cells/µL or increase in serum creatinine (SCr) by <1.5 times the baseline; severe, defined as white-cell count greater than 15,000 cells/µL or increase in SCr by >1.5 times the baseline; and fulminant, defined as the criteria above for severe with shock, hypotension, ileus, or megacolon)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951702
|Principal Investigator:||Ryan E Medas, PharmD||St. Luke's Hospital|