Early Phase 1 Study of Pulse Dose Ceftriaxone IV Treatment for Adults with Post-Treatment Lyme Disease Symptoms Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Symptom Improvement

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.

Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease