RECRUITING

Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06611111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 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

Inclusion Criteria

Exclusion 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.

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.
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

Contacts and Locations

Study Contact

Keely Terrillion

CONTACT

315-464-9869

trials@upstate.edu

Principal Investigator

Kristopher Paolino, MD

PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Study Locations (Sites)

SUNY Upstate Medical University, Upstate Global Health Institute

East Syracuse, New York, 13057

United States

Collaborators and Investigators

Sponsor: State University of New York - Upstate Medical University

Kristopher Paolino, MD, PRINCIPAL_INVESTIGATOR, State University of New York - Upstate Medical University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-01

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Pulse Dose
Ceftriaxone
PTLDS
Chronic Lyme Disease

Additional Relevant MeSH Terms

Post-Treatment Lyme Disease