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Ibezapolstat for Clostridioides Difficile Infection
Study Summary
This trial is testing a new drug to treat C. difficile infection. The drug is safe and effective, and also affects the microbiome.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had a procedure called a fecal transplant in the past 3 months.You have diarrhea that is not caused by a specific bacteria called C. difficile.Your immune system is weakened, making it harder for your body to fight off infections or diseases.You are currently receiving strong chemotherapy, radiation therapy, or other treatments for cancer.You have received a medication called intravenous immunoglobulin within the last 3 months before starting the study drug.You are currently taking Saccharomyces boulardii and are not willing to stop taking it during the study.You have a condition called inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, or a similar condition called irritable bowel syndrome with chronic diarrhea.You have taken or are currently taking medications for Clostridium difficile infection.You have received a vaccine to protect against C. difficile infection or its toxins.You are male or female 18 to 90 years of age, inclusive, at the time of Screening.
- Group 1: Ibezapolstat
- Group 2: Vancomycin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the trial have any age restrictions?
"This clinical trial is seeking participants aged 18 to 90. Conversely, there exist separate 209 studies intended for those younger than 18 and 663 specifically designed for seniors 65 years of age or older."
What risks have been noted with the use of Ibezapolstat?
"Ibezapolstat has been given a safety rating of 2, as it is in Phase 2 clinical trials - meaning there are some data points that support its safety but none yet to confirm efficacy."
Are any Canadian health centers currently administering this trial?
"Currently, 45 clinical trial sites across the US are enrolling patients. Notable locations include Lynchburg, Camarillo and Miami; however there are numerous other centres participating in this research endeavour to which you should consider travelling if accepted into the study."
Could I potentially qualify for this medical research project?
"This clinical investigation is searching for 74 volunteers, whose ages span from 18 to 90 years old and who are currently suffering from clostridium infections. To qualify, potential candidates must be of any gender between the designated age range, experience diarrhea (defined as 3 unformed stools within 24 hours before dosing) and meet the other requirements outlined in Appendix 2."
To what ailment is Ibezapolstat typically recommended as a remedy?
"Ibezapolstat is an effective remedy for staphylococcal infections, staph-induced enterocolitis and other illnesses caused by the Staphylococcus aureus strain."
How many individuals are actively participating in this clinical research?
"In order for the clinical trial to be considered successful, 74 participants that meet the specified criteria must register. Potential enrollees can visit either Acurx Site #109 in Lynchburg, Virginia or Acurx Site #125 with Dr Karen Simon in Camarillo, California."
Are there any other reports that have investigated Ibezapolstat?
"Ibezapolstat was first tested at the Sacramento Pediatric Gastroenterology center in 2010. Currently, there are 153 finished clinical trials and 55 active ones taking place mainly around Lynchburg, Virginia."
Is this research still open for enrollment?
"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical study is actively recruiting participants, with 74 individuals sought out from 45 distinct sites since its commencement in March 2020 and last update of November 2022."
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