Vancomycin Oral
DrugThis arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Other names: Oral vancomycin; vancomycin
NCT Number: NCT02951702
The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.
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Notify Me65 year and older
All sexes
Interventional
Phase 4
Clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. Current practice throughout the United States is targeted at infection prevention measures such as hand washing and isolation. Despite these measures, incidence of Clostridium difficile infections continue to rise as some institutions, including our own. Recently, a study published in Clinical Infectious Diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. No studies to date have evaluated primary prophylaxis with oral vancomycin. This will be a single center, prospective study to evaluate oral vancomycin use as primary Clostridium difficile prophylaxis. Patients treated by infectious disease physicians will be identified as "high risk" and after pager notification the ID physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. Risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. Oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for Clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Other names: Oral vancomycin; vancomycin
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 frame: Within 4 weeks from completion of antibiotic treatment
This is the time from the start of antibiotics to the diagnosis of clostridium difficile.
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)
St. Luke's Hospital, Chesterfield, Missouri
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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