Ceftriaxone for Lyme Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
You will need to stop taking antibiotics used to treat Lyme disease, like doxycycline or amoxicillin, for at least 6 weeks before joining the study and remain off them during the treatment phase. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.
Is ceftriaxone generally safe for treating Lyme disease?
Ceftriaxone is generally well tolerated in treating Lyme disease, with studies showing it does not usually require stopping treatment due to side effects. However, there are rare cases where serious complications like low white blood cell count, fever, liver issues, and diarrhea have occurred, especially when used without clear evidence of Lyme disease.12345
How does the drug ceftriaxone differ from other treatments for Lyme disease?
Ceftriaxone is unique for Lyme disease treatment because it is administered intravenously (directly into the vein) and is highly effective even in short courses, which can be more convenient and potentially reduce side effects compared to longer treatments. It is particularly effective for late-stage Lyme disease and cases involving the central nervous system.12678
Who Is on the Research Team?
Bindu Balani, MD
Principal Investigator
Hackensack Meridian Health
Are You a Good Fit for This Trial?
This trial is for individuals who have been treated for Lyme disease but continue to experience symptoms, suggesting Post-Treatment Lyme Disease Syndrome (PTLDS). Participants must be able to commit to a 6-week treatment plan with follow-ups extending up to 12 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pulse-dosed ceftriaxone or placebo intravenously every 5 days for approximately 6 weeks
Unblinding
Participants are unblinded at 6 months, and those in the placebo group are offered ceftriaxone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ceftriaxone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hackensack Meridian Health
Lead Sponsor
Columbia Clinical Trials Network for Lyme and Other Tick-Borne Diseases
Collaborator