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New treatment option for Clostridium Difficile Infection
Official title Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
ClinicalTrials.gov ID: NCT07221370
What this study is testing
What is Vancomycin 125mg?
Vancomycin 125mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for clostridium difficile infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must meet all 3 criteria:
- Adults aged 18 years and older.
- Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.
- Admitted ≥ 72 hours into their index hospitalization.
- And must meet 2 additional of the following high-risk criteria
You likely can't join if
- Pregnant or breastfeeding women
- Currently incarcerated individuals
- Individual or legal representative whose informed consent cannot be obtained
- Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
- Receiving concurrent treatment with metronidazole for any indication
- One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion
See the full eligibility criteria
- Must meet all 3 criteria:
- Adults aged 18 years and older.
- Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.
- Admitted ≥ 72 hours into their index hospitalization.
- And must meet 2 additional of the following high-risk criteria
- Age ≥ 65 years
- Previous residence in long-term care facility
- Previous proton pump inhibitor use (chronic or as needed)
- Inflammatory bowel disease
- Immunocompromised state (HIV/AIDS; transplant recipient; receipt of prednisone 20 mg daily for at least one month, immunosuppressants, or chemotherapy)
- End stage renal disease (ESRD)
- Diabetes mellitus
- Receipt of catecholamines (norepinephrine at a rate of ≥ 5 mcg/min)
- Hospitalized ≤ 30 days prior to the index hospitalization.
- Received systemic antibiotics during that prior hospitalization.
- Pregnant or breastfeeding women
- Currently incarcerated individuals
- Individual or legal representative whose informed consent cannot be obtained
- Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
- Receiving concurrent treatment with metronidazole for any indication
- One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion
- Receiving concurrent probiotics
- Allergic reaction or had a contraindication for use of enteral vancomycin
- History of prior CDI within the past 90 days of randomization
- Had suspected active CDI prior to inclusion
- Infection requiring more than 14 21 days of systemic antibiotics during index hospitalization
The study team makes the final eligibility decision.
Where it's taking place
- Moreno Valley, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moreno Valley, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.