Challenge Non-Typhoidal Salmonella (CHANTS) Study (NCT05870150) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Challenge Non-Typhoidal Salmonella (CHANTS) Study
United Kingdom80 participantsStarted 2023-08-31
Plain-language summary
This protocol describes the challenge non-typhoidal Salmonella (CHANTS) study. This is a first-in-human phase 1, double-blinded, randomised, dose-escalation human infection study, conducted in healthy volunteers aged 18 to 50 years. The primary objective of the study is to perform a dose escalation with two strains (ST19 or ST313) to determine the infectious dose required for 60-75% of volunteers to develop Salmonellosis using a composite diagnostic criterion. The secondary objectives of the study are to describe and compare the clinical and laboratory features following controlled human infection. It is hoped that the successful establishment of an NTS human challenge model can be used in the future to test candidate vaccines for NTS disease.
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:
Participants must satisfy all the following criteria to be considered eligible for the study:
* Agree to give informed consent for participation in the study.
* Aged between 18 and 50 years inclusive at time of challenge.
* In good health as determined by medical history, physical examination, and clinical judgment of the study team.
* Agree (in the study team's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
* Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
* Agree to allow study staff to contact his or her GP to access the participant's medical history and vaccination records.
* Agree to allow UKHSA and the local health protection unit to be informed of their participation in the study.
* Agree to give his or her close contacts written information informing them of the participant's involvement in the study and offer them voluntary screening for Salmonella carriage.
* Agree to a period of inpatient quarantine whilst symptomatic (In exceptional circumstances, the duration of inpatient quarantine may be extended.)
* Agree to have 24-hour contact with study staff during the four weeks post challenge and can ensure that they are contactable by mobile phone for the duration of the study period until antibiotic completion.
* Agree to allow the study team to hold the name and 24-hour contact …
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
The dose in CFU of Salmonella enterica subspecies enterica serovar Typhimurium (S. Typhimurium) 4/74 and D23580 strains required for 60-75% of volunteers to develop systemic Salmonellosis following oral challenge
Timeframe: Up to Day 14 post challenge (Inclusive)