Clostridium Difficile Infection, Prophylaxis, Vancomycin
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVancomycin Oral
This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician
Sponsors
St. Luke's Hospital, Chesterfield, Missouri
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* High-risk patients defined as: age older than 65, on gastric acid suppression, and select antibiotics * Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists * Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem
Exclusion criteria
* Failure to meet all three requirements for high risk * Vancomycin allergy * Active clostridium difficile infection prior to inclusion * Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper) * Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin) * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clostridium Difficile Infection Occurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clostridium Difficile Infection Occurence | 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 | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control This will be the historical arm that has not received oral vancomycin but match criteria for high risk | 34 |
| 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 | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Vancomycin | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 51 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 75 years | 75 years | 76 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 51 Participants | 34 Participants |
| Region of Enrollment United States | 17 Participants | 51 Participants | 34 Participants |
| Sex: Female, Male Female | 13 Participants | 30 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 21 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 17 |
| other Total, other adverse events | 0 / 34 | 0 / 17 |
| serious Total, serious adverse events | 0 / 34 | 0 / 17 |
Outcome results
Primary
Clostridium Difficile Infection Occurrence
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Clostridium Difficile Infection Occurrence | 2 Participants |
| Vancomycin | Clostridium Difficile Infection Occurrence | 0 Participants |
Secondary
Clostridium Difficile Infection Severity
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Clostridium Difficile Infection Severity | Mild-Mod | 1 participants |
| Control | Clostridium Difficile Infection Severity | Severe | 1 participants |
| Vancomycin | Clostridium Difficile Infection Severity | Mild-Mod | 0 participants |
| Vancomycin | Clostridium Difficile Infection Severity | Severe | 0 participants |
Secondary
Time to Clostridium Difficile Infection Occurence
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Time to Clostridium Difficile Infection Occurence | 2 days |
| Vancomycin | Time to Clostridium Difficile Infection Occurence | 0 days |