Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorState University of New York - Upstate Medical University

About this trial

The goal of this clinical trial is to learn if an FDA approved drug, Ceftriaxone, given intermittently, can treat people between 18 and 75 years old with a history of Lyme disease, who are still experiencing persistent or returning symptoms after they have completed treatment. The main questions it aims to answer are:

* Will giving Ceftriaxone approximately every 5 days for 6 weeks be safe and well tolerated when compared to a group that receives placebo (a look-alike substance that contains no drug)? * Will giving Ceftriaxone improve symptoms?

Participants will be asked to do the following:

* Come to the clinic approximately every 5-6 days to receive an IV infusion of either the Ceftriaxone or placebo. * Answer questions about their level of tiredness, body pain, general health and physical ability, sleep, anxiety, depression and any suicidal thoughts. * Give blood so we can make sure your body is handling the drug okay or to help us learn more about how the drug is affecting the persistent Lyme disease symptoms.

Eligibility criteria

Qualifiers

Age 18 to 75 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ceftriaxone (Rocephin®)
  • Dextrose 5% (D5W)

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

State University of New York - Upstate Medical University

Lead sponsor

Steven & Alexandra Cohen Foundation

Collaborator