Trial Outcomes & Findings for Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics (NCT NCT02951702)

NCT ID: NCT02951702

Last Updated: 2017-12-27

Results Overview

The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: Within 4 weeks from the completion of antibiotic treatment
• Results posted on: 2017-12-27

Participant Flow

Participant milestones

Measure	Control This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"	Vancomycin This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Overall Study STARTED	34	17
Overall Study COMPLETED	34	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics

Baseline characteristics by cohort

Measure	Control n=34 Participants This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"	Vancomycin n=17 Participants This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician	Total n=51 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Age, Continuous	76 years n=5 Participants	75 years n=7 Participants	75 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	4 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=34 Participants This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"	Vancomycin n=17 Participants This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Clostridium Difficile Infection Occurrence	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 4 weeks from completion of antibiotic treatment

This is the time from the start of antibiotics to the diagnosis of clostridium difficile.

Outcome measures

Measure	Control n=34 Participants This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"	Vancomycin n=17 Participants This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Time to Clostridium Difficile Infection Occurence	2 days Interval 0.0 to 2.0	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control n=34 Participants This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"	Vancomycin n=17 Participants This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Vancomycin Oral: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Clostridium Difficile Infection Severity Mild-Mod	1 participants	0 participants
Clostridium Difficile Infection Severity Severe	1 participants	0 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ryan Medas, Pharm.D.

St. Luke's Hospital

Phone: 314-205-6053

Email: ryan.medas@stlukes-stl.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place