Actively Recruiting
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
Led by State University of New York - Upstate Medical University · Updated on 2026-03-19
44
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
S
State University of New York - Upstate Medical University
Lead Sponsor
S
Steven & Alexandra Cohen Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 at the time of consent
- Ability and willingness to sign informed consent
- Available for the study period
- Prior well-defined or probable Lyme disease infection and meet definition of PTLDS
- Consent to release past medical records
- Fatigue score of 4 or higher interfering with daily activities
- Off antibiotics targeting Lyme disease for at least 6 weeks before enrollment and willing to stay off during treatment
You will not qualify if you...
- Female who is pregnant or lactating
- Women planning to become pregnant during treatment period (about 45 days)
- Lyme disease diagnosis based only on positive Lyme IgM immunoblot
- History of allergy or intolerance to cephalosporins
- Symptoms related to Lyme disease present for more than 10 years
- Infection with HIV-1, hepatitis B, or hepatitis C (except well-controlled HIV on ART with CD4 >200)
- Diagnosis of Bipolar Disorder, Schizophrenia, recent hospitalization for mental health, or moderate to high suicide risk
- Known rheumatologic or similar diseases that may interfere with study
- Severe allergic reactions to cephalosporins or penicillins
- Planned travel interfering with study visits
- Significant physical exam abnormalities or chronic conditions affecting safety
- Participation in another drug, vaccine, or device trial in last 4 weeks or during this trial
- Prior Clostridium difficile infection
- Currently taking warfarin (Coumadin)
- Unable to comply with study requirements
- Investigator discretion
AI-Screening
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Trial Site Locations
Total: 1 location
1
SUNY Upstate Medical University, Upstate Global Health Institute
East Syracuse, New York, United States, 13057
Actively Recruiting
Research Team
K
Keely Terrillion
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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