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.
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
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
Parallel
Ceftriaxone (Rocephin®)
DrugSlightly yellow liquid.
Dextrose 5% (D5W)
DrugColorless liquid
Number of abnormal laboratory measurements
Total number of all abnormal labs
Intensity of Abnormal Laboratory Measurements
Graded according clinical laboratory normals and FDA toxicity scale
Duration of Abnormal Laboratory Measurements
Number of days of abnormal lab
Occurrence of adverse events
Total number of adverse events
Fatigue Severity Scale
Clinical improvement
SAFTEE assessment
Adverse events
SF-36 continuous variables
Primary functional change with physical and mental summary indices as continuous variables.
SF-36 Responder-Nonresponder
Primary functional change with the physical and mental summary indices as either responder or nonresponder.
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State University of New York - Upstate Medical University
Lead sponsor
Steven & Alexandra Cohen Foundation
Collaborator
