Ceftriaxone treatment for persistent Lyme disease symptoms

Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease

This study is testing if a new way of giving the antibiotic Ceftriaxone can help adults aged 18 to 75 who still have symptoms after being treated for Lyme disease feel better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: State University of New York - Upstate Medical University (Academic / other)
• Locations: 1 site (East Syracuse, New York)
• Trial ID: NCT06611111 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of Ceftriaxone, an FDA-approved antibiotic, administered in a pulse dose regimen to adults aged 18 to 75 who are experiencing persistent symptoms after Lyme disease treatment. Participants will receive intravenous infusions of either Ceftriaxone or a placebo every 5 days for 6 weeks, followed by assessments of their symptoms and overall health. The study will include various questionnaires to measure fatigue, pain, mental health, and other factors, with follow-up evaluations extending up to one year post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a history of Lyme disease and ongoing symptoms that interfere with daily functioning.

Not a fit: Patients who are currently pregnant or lactating, or those who have not been off antibiotics for at least 6 weeks prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate persistent symptoms in patients suffering from Post-Treatment Lyme Disease.

How similar studies have performed: While there is limited research specifically on pulse dosing Ceftriaxone for this condition, similar studies exploring alternative treatments for Post-Treatment Lyme Disease have shown varying degrees of success.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 75 at the time of consent
2. Ability and willingness to sign informed consent
3. Available for the study period
4. Must have met the definition of a prior well-defined or probable Lyme disease infection, AND meet the definition of PTLDS
5. Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit
6. 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)
7. 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:

1. Female: pregnant or lactating
2. Women who intend to become pregnant during the treatment study period (approximately 45 days)
3. Patients with a diagnosis of Lyme disease based on only a positive Lyme IgM immunoblot
4. A history of cephalosporin allergy or significant intolerance
5. Lyme related symptoms that have been present for greater than 10 years
6. 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.
7. 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
8. 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
9. 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)
10. 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)
11. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety
12. 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
13. Prior history of Clostridium difficile infection
14. Currently taking warfarin (Coumadin)
15. Unable to comply with study requirements
16. Clinician discretion

Where this trial is running

East Syracuse, New York

• SUNY Upstate Medical University, Upstate Global Health Institute — East Syracuse, New York, United States (Recruiting)

Study contacts

• Principal investigator: Kristopher Paolino, MD — State University of New York - Upstate Medical University
• Study coordinator: Keely Terrillion

Conditions Post-Treatment Lyme Disease; Pulse Dose; Ceftriaxone; PTLDS; Chronic Lyme Disease