Actively Recruiting
Phase 1 Randomized Double-Blind Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
Led by State University of New York - Upstate Medical University · Updated on 2026-03-19
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
State University of New York - Upstate Medical University
Lead Sponsor
S
Steven & Alexandra Cohen Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether an FDA-approved drug called Ceftriaxone, given intermittently, can help adults aged 18 to 75 who have a history of Lyme disease and continue to experience persistent or returning symptoms after completing treatment. The study aims to determine if Ceftriaxone, given approximately every 5 days for 6 weeks, is safe and well tolerated compared to a placebo and whether it improves symptoms in these individuals. Participants will receive intravenous infusions of either 2 grams of Ceftriaxone or a placebo of dextrose 5% in water, administered about every 5 days for a total of 9 treatments over 6 weeks. After treatment, participants will have follow-up visits one month after the last treatment and again at approximately 3 and 6 months from the start of the study. At 6 months, the study will be unblinded, and those who initially received placebo may repeat the treatment with Ceftriaxone. Participants originally treated with Ceftriaxone will receive a phone follow-up at one year. During the study, participants will attend clinic visits for infusions and complete questionnaires assessing fatigue, physical functioning, general health, anxiety, depression, sleep, and suicidal thoughts. Blood samples will be collected to monitor safety and understand how the drug affects Lyme disease symptoms. Researchers will measure laboratory abnormalities, adverse events, and symptom changes over one year to assess safety and treatment impact.
CONDITIONS
Brief Title
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 at the time of consent
- Ability and willingness to sign informed consent
- Available for the study period
- Must have had a prior well-defined or probable Lyme disease infection and meet criteria for Post-Treatment Lyme Disease Syndrome
- Consent to release medical history records from relevant healthcare providers
- Fatigue severity score of 4 or higher interfering with daily activities
- Off antibiotics used for Lyme disease for at least 6 weeks before enrollment and willing to remain off during treatment
You will not qualify if you...
- Female who is pregnant or breastfeeding
- Women planning pregnancy during the treatment period (about 45 days)
- Lyme disease diagnosis based only on positive Lyme IgM immunoblot
- History of allergy or significant intolerance to cephalosporin antibiotics
- Symptoms lasting more than 10 years
- Infection with HIV-1, hepatitis B, or hepatitis C (except well-controlled HIV with CD4 count over 200)
- Diagnosis of bipolar disorder, schizophrenia, recent hospitalization for mental health, or other psychiatric conditions that prevent participation
- Concurrent rheumatologic or similar diseases that may affect study participation
- Severe allergic reactions to cephalosporins or penicillins
- Planned travel interfering with study visits
- Significant physical exam abnormalities or chronic conditions impacting safety
- Participation in other medical trials recently or planned during this trial
- Prior history of Clostridium difficile infection
- Currently taking warfarin
- Unable to comply with study requirements
- Investigator discretion exclusions
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive intravenous Ceftriaxone or placebo infusions in a pulse dose fashion approximately every 5 days for 6 weeks, totaling 9 IV infusions.
9 visits (in-person) approximately every 5 days
Duration - Up to 1 year
Participants complete study visits including questionnaires and safety labs at 1 month post last treatment and at approximately 3 and 6 months from study start. At 6 months, the study is unblinded and placebo group participants may repeat treatment visits. Participants originally receiving Ceftriaxone receive a phone call follow-up at 1 year.
3 in-person visits and 1 phone call follow-up
Trial Site Locations
Total: 1 location
1
SUNY Upstate Medical University, Upstate Global Health Institute
East Syracuse, New York, United States, 13057
Actively Recruiting
Research Team
K
Keely Terrillion
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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