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Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. 2 versions Re-verified since Jan 15, 2026, no change to tracked fieldsv6-v7
  2. Primary and study completion dates: Mar 2026 to Dec 2026v5
  3. Start date changed from estimate of Jan 2025 to Feb 3, 2025
    • Secondary endpoints: details revised at 1 of 7 entries
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: Nov 2024 to Jan 2025
    • Primary completion date: Dec 2025 to Mar 2026
    • Study completion date: Feb 2026 to Mar 2026
    • Eligibility criteria expanded, about 14 words
    • Site details revised
  5. Start date: Sep 2024 to Nov 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Dec 2025 to Feb 2026
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The goal of this clinical trial is to learn if an FDA approved drug, Ceftriaxone, given intermittently, can treat people between 18 and 75 years old with a history of Lyme disease, who are still experiencing persistent or returning symptoms after they have completed treatment. The main questions it aims to answer are: * Will giving Ceftriaxone approximately every 5 days for 6 weeks be safe and well tolerated when compared to a group that receives placebo (a look-alike substance that contains no drug)? * Will giving Ceftriaxone improve symptoms? Participants will be asked to do the following: * Come to the clinic approximately every 5-6 days to receive an IV infusion of either the Ceftriaxone or placebo. * Answer questions about their level of tiredness, body pain, general health and physical ability, sleep, anxiety, depression and any suicidal thoughts. * Give blood so we can make sure your body is handling the drug okay or to help us learn more about how the drug is affecting the persistent Lyme disease symptoms.
Trial Details
NCT Number NCT06611111
Lead Sponsor State University of New York - Upstate Medical University
Collaborators: Steven & Alexandra Cohen Foundation
Conditions
(from sponsor)		 Post-Treatment Lyme Disease
Related terms Post-Lyme Disease Syndrome
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov