20 Participants Needed

Ceftriaxone for Lyme Disease

NA
BB
Overseen ByBindu Balani, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Hackensack Meridian Health

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?

BB

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

Ability and willingness to sign informed consent
Available for the study period
I experience fatigue that affects my daily activities.
See 3 more

Exclusion Criteria

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)
I am not pregnant or breastfeeding.
I have had a Clostridium difficile infection before.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pulse-dosed ceftriaxone or placebo intravenously every 5 days for approximately 6 weeks

6 weeks
9 visits (in-person)

Unblinding

Participants are unblinded at 6 months, and those in the placebo group are offered ceftriaxone

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ceftriaxone
Trial Overview The study is testing the effectiveness of Ceftriaxone, an antibiotic, given every five days over six weeks against a placebo. Patients are randomly assigned in equal numbers and will not know which group they're in until after six months.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ceftriaxone 2 GMExperimental Treatment1 Intervention
Administration of IV ceftriaxone or D5W. Subjects will be infused approximately every 5 days (+/- 1 day) over the course of \~6 weeks. Subjects will receive a total of 9 infusions throughout the treatment phase of the study, with the last infusion tentatively scheduled for Day 41 (+/- 3 days).
Group II: PlaceboPlacebo Group1 Intervention
Placebo \[dextrose (5% in water), (D5W)\] IV following the same infusion schedule as the ceftriaxone arm.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

Columbia Clinical Trials Network for Lyme and Other Tick-Borne Diseases

Collaborator

Trials
1
Recruited
20+

Published Research Related to This Trial

Ceftriaxone is highly effective against Lyme disease, with a minimum bactericidal concentration (MBC) of 0.050 microg/ml for Borrelia burgdorferi, the bacteria causing the disease.
In a study with C3H mice, a 5-day regimen of ceftriaxone (50 mg/kg/dose) was 100% effective in sterilizing infected tissues, suggesting that shorter antibiotic courses could be effective for treating early uncomplicated Lyme disease.
Efficacy of short-course ceftriaxone therapy for Borrelia burgdorferi infection in C3H mice.Pavia, C., Inchiosa, MA., Wormser, GP.[2021]
In a study of 35 patients with late-stage Lyme borreliosis treated with a 14-day course of ceftriaxone, 73% showed complete response or marked improvement after 36 months, indicating the treatment's efficacy.
Ceftriaxone was well tolerated, with no patients needing to discontinue treatment due to adverse reactions, highlighting its safety in this patient population.
Long-term results in patients with Lyme arthritis following treatment with ceftriaxone.Valesová, H., Mailer, J., Havlík, J., et al.[2019]
A case study highlights the risks of empiric antibiotic treatment in patients suspected of having Lyme disease, as a patient treated with intravenous ceftriaxone developed serious complications despite negative tests for the disease.
The complications included granulocytopenia, fever, hepatitis, and Clostridium difficile-associated diarrhea, emphasizing the need for physicians to carefully consider the risks of treating without definitive evidence of Lyme disease.
Life-threatening complications of empiric ceftriaxone therapy for 'seronegative Lyme disease'.Nadelman, RB., Arlin, Z., Wormser, GP.[2019]

Citations

Efficacy of short-course ceftriaxone therapy for Borrelia burgdorferi infection in C3H mice. [2021]
Long-term results in patients with Lyme arthritis following treatment with ceftriaxone. [2019]
Life-threatening complications of empiric ceftriaxone therapy for 'seronegative Lyme disease'. [2019]
Ceftriaxone in the treatment of Lyme neuroborreliosis. [2022]
Adjuvanted Lyme disease vaccine: a review of its use in the management of Lyme disease. [2018]
Use of third-generation cephalosporins. Spirochetes. [2019]
Treatment of late Lyme borreliosis--randomised comparison of ceftriaxone and penicillin. [2019]
Doxycycline versus ceftriaxone for the treatment of patients with chronic Lyme borreliosis. [2018]
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