Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-25 @ 8:16 AM
Study NCT ID:
NCT02237859
Status:
UNKNOWN
Last Update Posted:
2014-09-11
First Post:
2014-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Sponsor:
Corewell Health West
Organization:
Study Overview
Official Title:
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.
Detailed Description:
To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics.
This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:
1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).
2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water).
Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions.
A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment.
You will be contacted again by telephone at 1, 3, and 6 months after completion of the study medication to inquire about your general health and any changes in health status.
Other medical information from your records and charts may also be collected by us for purposes of review for this study.
This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:
1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).
2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water).
Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions.
A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment.
You will be contacted again by telephone at 1, 3, and 6 months after completion of the study medication to inquire about your general health and any changes in health status.
Other medical information from your records and charts may also be collected by us for purposes of review for this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DDI.FY14.01 | OTHER_GRANT | Digestive Disease Institute | View |