Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model … (NCT05182749) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
United States52 participantsStarted 2023-02-23
Plain-language summary
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 50 years.
. Access to CVD clinical site and available and willing to be followed for the planned duration of the study, including all follow-up visits.
. Able and willing to provide informed consent.
. Willing to participate after all aspects of trial explained.
. Assessment of understanding:
. Volunteer demonstrates understanding of this study;
. Completes a questionnaire prior to first treatment with verbal demonstration of understanding of all questionnaire items answered incorrectly;
. Receives a passing score of 70% or higher on the Comprehension Assessment Tool.
Exclusion criteria
. Blood products received within 120 days before first treatment.
. Investigational research agents received within 30 days before first treatment.
. Body mass index (BMI) less than 19.0 kg/m2 or greater than 36.0 kg/m2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions
Timeframe: Up to Day 90
2
Phase 2a: Onset of Clinical Shigellosis Post-Challenge
Timeframe: Day 2 to Day 7 (Post-Challenge)
3
Phase 2a: Number of Solicited and Unsolicited Adverse Reactions