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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
Sponsor:
Information provided by (Responsible Party):
Ryan Medas, St. Luke's Hospital, Chesterfield, Missouri

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Clostridium Difficile Infection
Prophylaxis
Vancomycin
Intervention Drug: Vancomycin Oral
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Vancomycin
Hide Arm/Group Description This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

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

Period Title: Overall Study
Started 34 17
Completed 34 17
Not Completed 0 0
Arm/Group Title Control Vancomycin Total
Hide Arm/Group Description This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

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 of all reporting groups
Overall Number of Baseline Participants 34 17 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 17 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
34
 100.0%
17
 100.0%
51
 100.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 17 participants 51 participants
76
(65 to 90)
75
(65 to 86)
75
(65 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 17 participants 51 participants
Female
17
  50.0%
13
  76.5%
30
  58.8%
Male
17
  50.0%
4
  23.5%
21
  41.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 17 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
34
 100.0%
17
 100.0%
51
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 34 participants 17 participants 51 participants
34
 100.0%
17
 100.0%
51
 100.0%
1.Primary Outcome
Title Clostridium Difficile Infection Occurrence
Hide Description 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 the completion of antibiotic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Vancomycin
Hide Arm/Group Description:
This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

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 Number of Participants Analyzed 34 17
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.9%
0
   0.0%
2.Secondary Outcome
Title Time to Clostridium Difficile Infection Occurence
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Vancomycin
Hide Arm/Group Description:
This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

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 Number of Participants Analyzed 34 17
Mean (Full Range)
Unit of Measure: days
2
(0 to 2)
0
(0 to 0)
3.Secondary Outcome
Title Clostridium Difficile Infection Severity
Hide Description 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)
Time Frame Within 4 weeks from completion of antibiotic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Vancomycin
Hide Arm/Group Description:
This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

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 Number of Participants Analyzed 34 17
Measure Type: Number
Unit of Measure: participants
Mild-Mod 1 0
Severe 1 0
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Vancomycin
Hide Arm/Group Description This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

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

All-Cause Mortality
Control Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/17 (0.00%) 
Underpowered study; primary outcome relied upon patient's developing CDI while in the hospital or follow up at the study hospital.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ryan Medas, Pharm.D.
Organization: St. Luke's Hospital
Phone: 314-205-6053
Publications:
Responsible Party: Ryan Medas, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier: NCT02951702     History of Changes
Other Study ID Numbers: 940920-2
First Submitted: October 30, 2016
First Posted: November 1, 2016
Results First Submitted: October 3, 2017
Results First Posted: December 27, 2017
Last Update Posted: December 27, 2017