Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 19 participants (planned 72)
    • Primary completion date changed from estimate of Dec 1, 2026 to Sep 29, 2026
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 3 of 15 entries
    • Study description revised
    • Site details revised
  2. Primary and study completion dates pushed to Dec 1, 2026v4
  3. Primary completion date: Jun 1, 2024 to Dec 1, 2025
    • Study completion date: Jun 1, 2024 to Jun 1, 2026
    v3
  4. Primary completion date: Jun 1, 2023 to Jun 1, 2024v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05847322
Lead Sponsor University of Southampton
Conditions
(from sponsor)		 Healthy Volunteer Study
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov