Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for … (NCT05847322) | Clinical Trial Compass
RecruitingNot Applicable
Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
United Kingdom72 participantsStarted 2022-12-06
Plain-language summary
Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B. pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after inoculation or at symptom onset, whichever occurs first
Secondary objectives - To measure the rate of natural clearance of carriage of B. pertussis following nasal inoculation
* To assess the kinetics of B. pertussis colonisation density following nasal inoculation
* To describe the microevolution of B. pertussis and adaptation of the resident microbiome during B. pertussis carriage
* To measure B. pertussis-specific antibody and cellular immunological responses in healthy volunteers during colonisation with B. pertussis - To identify biomarkers that correlate with natural clearance of B. pertussis carriage after induced B. pertussis colonisation
* To detect transmission of B. pertussis to bedroom contacts of inoculated volunteers during prolonged asymptomatic colonisation
Who can participate
Age range
18 Years – 55 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.
Exclusion criteria
. unimmunised or partially immunised children and infants aged \< 1 year
. pregnant women \>32 weeks who have not received pertussis vaccination at least a week prior to contact
. immunosuppressed individuals
. frail individuals
. healthcare workers regularly working with vulnerable individuals as above
. unimmunised or partially immunised children and infants aged \< 1 year
. pregnant women \>32 weeks who have not received pertussis vaccination at least a week prior to 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
To assess the incidence of solicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers
Timeframe: 6 weeks.
2
To assess the incidence of unsolicited adverse events during prolonged colonisation with Bordetella pertussis following nasal inoculation of healthy adult volunteers
Timeframe: 6 weeks.
3
To establish the rate of natural clearance of Bordetella pertussis colonisation as detected by nasal wash.
Timeframe: 6 weeks.
4
To establish the rate of natural clearance of Bordetella pertussis colonisation as detected by nasopharyngeal swab