Ceftriaxone for Post-Treatment Lyme Disease

Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease

NCT06785402•Hackensack Meridian Health

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 controlled HIV, who are on ART with a CD4 count of \>200 will be allowed to participate.
•Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition to include any finding of increased suicide risk per the CSSRS scale (score 6 or greater), which in the opinion of the investigator prevents the subject from participating in the study
•Known concurrent rheumatologic or similar disease thought to interfere with study participation or confound results at the discretion of the investigator. These may include but are not limited to rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, psoriasis, fibromyalgia, chronic fatigue syndrome/myalgic encephalomyelitis, or obstructive sleep apnea
•Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous treatment with a cephalosporin antibiotic, or severe allergic reaction to penicillins (e.g. anaphylaxis or severe rash with Stevens Johnson syndrome or similar)
+6 more criteria

Locations (1)

Hackensack University Medical Center

Hackensack, New Jersey, United States

Key Dates

Start Date

February 15, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Post-Treatment Lyme Disease Syndrome

Interventions

Ceftriaxone treatment

DRUG

Placebo

DRUG

Contacts

Bindu Balani, MD

CONTACT

201 487 - 4088 bindu.balani@hmhn.org

Nicole AlMallah

CONTACT

nicole.almallah@hmhn.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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