Actively Recruiting
Ceftriaxone for Post-Treatment Lyme Disease
Led by Hackensack Meridian Health · Updated on 2026-04-03
20
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
H
Hackensack Meridian Health
Lead Sponsor
C
Columbia Clinical Trials Network for Lyme and Other Tick-Borne Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ceftriaxone for Post-Treatment Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent
- Ability and willingness to sign informed consent
- Available for the study period
- Have a prior well-defined or probable Lyme disease infection and meet the definition of PTLDS
- Consent to release medical history records and relevant photographs
- Experience fatigue interfering with job, school, or social activities (FSS score of 4 or higher)
- Have been off Lyme disease antibiotics for at least 6 weeks before enrollment and agree to remain off during treatment
You will not qualify if you...
- Female who is pregnant or lactating
- Women planning to become pregnant during the approximately 45-day treatment period
- Diagnosis of Lyme disease based only on positive Lyme IgM immunoblot
- History of allergy or significant intolerance to cephalosporin antibiotics
- Lyme symptoms present for more than 10 years
- Infection with HIV-1, hepatitis B, or hepatitis C (except well-controlled HIV on ART with CD4 count >200)
- Diagnosis of Bipolar Disorder or Schizophrenia, recent hospitalization for mental health, or high suicide risk
- Concurrent rheumatologic or similar diseases interfering with participation or results
- Severe allergic reactions to cephalosporins or penicillins
- Planned travel that would interfere with study visits
- Significant physical abnormalities or chronic conditions impacting safety
- Participation in another medical trial within 4 weeks before or during this trial
- Prior history of Clostridium difficile infection
- Unable to comply with study requirements
- Investigator’s discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
B
Bindu Balani, MD
CONTACT
N
Nicole AlMallah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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