WithdrawnPhase 1/2

Ceftriaxone for Post-Treatment Lyme Disease

Stopped: Enrollment challenges

United States0Started 2026-05-14

Plain-language summary

Lyme disease is a public health crisis in the US. It is estimated that over 400,000 cases occur every year with 10-20% of those infected going on to develop Post-Treatment Lyme disease Syndrome (PTLDS). The goal of this study is to investigate if giving Ceftriaxone every 5 days for about 6 weeks kills the organism that produces persistent Lyme infection. Enrolled participants will be randomized 1:1 receiving either pulse-dosed ceftriaxone or placebo \[dextrose (5% in water), (D5W)\], intravenously. Participants will be evaluated at each of the study visits, and then in a follow-up phase out to 12 months. They will be unblinded at 6 months and those randomized to the placebo group will be offered pulse-dosed ceftriaxone on the same schedule as those randomized to the drug group. All patients will be followed up for a total of 12 months post treatment initiation.

Who can participate

Age range

18 Years – 75 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.

Inclusion Criteria: * Age 18 to 75 years at the time of consent * Ability and willingness to sign informed consent * Available for the study period * Must have met the definition of a prior well-defined or probable Lyme disease infection, AND meet the definition of PTLDS * Provide consent for release of medical history records and photographs from primary care physician, college or university, urgent care or emergency room visit * Have a level of fatigue that interferes with their ability to function in their job, schooling, or other social/personal activities (FSS score of 4 or higher) * Subjects will need to have been off of antibiotics (those standard antibiotics used to target Lyme disease to include doxycycline, amoxicillin, cefuroxime, azithromycin, ceftriaxone or penicillin) for at least 6 weeks prior to study enrollment and be willing to remain off of any outside antibiotics during the duration of the treatment component of the study. Exclusion Criteria: * Female: pregnant or lactating * Women who intend to become pregnant during the treatment study period (approximately 45 days) * Patients with a diagnosis of Lyme disease based on only a positive Lyme IgM immunoblot * A history of cephalosporin allergy or significant intolerance * Lyme related symptoms that have been present for greater than 10 years * Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus. Note: Subjects who have well con…

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

Safety of pulse-dosed ceftriaxone

Timeframe: 12 months post treatment initiation

Tolerability of pulse-dosed ceftriaxone

Timeframe: 12 months post treatment initiation

Study Feasibility

Timeframe: 6 month enrollment period

Trial details

NCT IDNCT06785402

SponsorHackensack Meridian Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-14

View on ClinicalTrials.gov More Post-Treatment Lyme Disease Syndrome trials