Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

Part of paid clinical trials in East Syracuse, New York.

Sponsor
State University of New York - Upstate Medical University
Study ID
NCT06611111
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Post-Treatment Lyme Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ceftriaxone (Rocephin®) — DRUG
    Slightly yellow liquid.
  • Dextrose 5% (D5W) — DRUG
    Colorless liquid

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ceftriaxone
    Participants will receive IV infusion of 2g Ceftriaxone, approximately every 5 days for 6 weeks for a total of 9 treatments.
  • Placebo Comparator: Placebo
    Participants will receive IV infusion of dextrose 5% in water, approximately every 5 days for 6 weeks for a total of 9 treatments

Primary Outcome Measure

Number of abnormal laboratory measurements [ Time Frame: 30 days post last treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SUNY Upstate Medical University, Upstate Global Health InstituteEast SyracuseNew York13057-

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SUNY Upstate Medical University, Upstate Global Health Institute· East Syracuse, NY

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