NCT06611111 · State University of New York - Upstate Medical University
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Ceftriaxone (Rocephin®)
Slightly yellow liquid.
DRUG
Dextrose 5% (D5W)
Colorless liquid
Primary outcome measures
Number of abnormal laboratory measurements
Time frame: 30 days post last treatment
Total number of all abnormal labs
Intensity of Abnormal Laboratory Measurements
Time frame: 30 days post final treatment
Graded according clinical laboratory normals and FDA toxicity scale
Duration of Abnormal Laboratory Measurements
Time frame: 30 days post final treatment
Number of days of abnormal lab
Occurrence of adverse events
Time frame: 30 days post last treatment
Total number of adverse events
Intensity adverse events
Time frame: 30 days post final treatment
Graded according FDA toxicity scale
Duration of adverse events
Time frame: 30 days post final treatment
Number of days per adverse event
Number of serious adverse events
Time frame: 1 year post study start
Total number
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit
- Have a level of fatigue that interferes with their ability to function in their job, schooling, or other social/personal activities (FSS score of 4 or higher)
- Subjects will need to have been off of antibiotics (those standard antibiotics used to target Lyme disease to include doxycycline, amoxicillin, cefuroxime, azithromycin, ceftriaxone or penicillin) for at least 6 weeks prior to study enrollment and be willing to remain off of any outside antibiotics during the duration of the treatment component of the study.
Exclusion criteria
- 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
- Lyme related symptoms that have been present for greater than 10 years
- Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus. Note: Subjects who have well controlled HIV, who are on ART with a CD4 count greater than 200 will be allowed to participate.
- Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition (to include any finding of increased suicide risk as identified by a rating of moderate or high risk on the CSSRS assessment), which in the opinion of the investigator prevents the subject from participating in the study
- Known concurrent rheumatologic or similar disease thought to interfere with study participation or confound results at the discretion of the investigator. These may include but are not limited to rheumatoid arthritis, systemic lupus erythematous, Sjogren's syndrome, scleroderma, psoriasis, fibromyalgia, chronic fatigue syndrome/myalgic encephalomyelitis, or obstructive sleep apnea
- 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)
- Planned travel during the study period that would interfere with the ability to complete all study visits (this can be a temporary exclusion with plan to schedule enrollment during a window of time during which they could attend their study visits)
- Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety
- 12\. Participation (active or follow-up phase) or planned participation in another vaccine, drug, or medical device in the 4 weeks prior to this trial, within 5 times the elimination half-life, whichever is longer, or during the trial
- Prior history of Clostridium difficile infection
- Currently taking warfarin (Coumadin)
- Unable to comply with study requirements
- Clinician discretion
Where
- East Syracuse, New York
Collaborators
Steven & Alexandra Cohen Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations