Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

Last updated: February 12, 2025
Sponsor: State University of New York - Upstate Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

Lyme Disease

Rash

Treatment

Ceftriaxone (Rocephin®)

Dextrose 5% (D5W)

Clinical Study ID

NCT06611111
2024-02-UMU
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 diseaseinfection, 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 usedto target Lyme disease to include doxycycline, amoxicillin, cefuroxime,azithromycin, ceftriaxone or penicillin) for at least 6 weeks prior to studyenrollment and be willing to remain off of any outside antibiotics during theduration of the treatment component of the study.

Exclusion

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 IgMimmunoblot

  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 greaterthan 200 will be allowed to participate.

  7. Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past yearfor a mental health disorder, or any other psychiatric condition (to include anyfinding of increased suicide risk as identified by a rating of moderate or high riskon the CSSRS assessment), which in the opinion of the investigator prevents thesubject from participating in the study

  8. Known concurrent rheumatologic or similar disease thought to interfere with studyparticipation or confound results at the discretion of the investigator. These mayinclude but are not limited to rheumatoid arthritis, systemic lupus erythematous,Sjogren's syndrome, scleroderma, psoriasis, fibromyalgia, chronic fatiguesyndrome/myalgic encephalomyelitis, or obstructive sleep apnea

  9. Hives, shortness of breath, swelling of the lips or throat, or hospitalizationrelated to a previous treatment with a cephalosporin antibiotic, or severe allergicreaction to penicillins (e.g. anaphylaxis or severe rash with Stevens Johnsonsyndrome or similar)

  10. Planned travel during the study period that would interfere with the ability tocomplete all study visits (this can be a temporary exclusion with plan to scheduleenrollment during a window of time during which they could attend their studyvisits)

  11. Significant screening physical examination abnormalities or chronic medicalcondition that in the opinion of the investigator may impact subject safety

  12. Participation (active or follow-up phase) or planned participation in anothervaccine, drug, or medical device in the 4 weeks prior to this trial, within 5times 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

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Ceftriaxone (Rocephin®)
Phase: 1
Study Start date:
February 03, 2025
Estimated Completion Date:
March 31, 2026

Study Description

This study will explore treating participants who are 18 to 75 years old with Post-Treatment Lyme Disease. IV Ceftriaxone will be delivered in a pulse dose fashion, approximately every 5 days for a total of 9 IV infusions over 6 weeks. Participants will return one month following last treatment, at approximately 3 and 6 months from study start. At each study visit, participants will be asked a number of questionnaires including the SAFTEE assessment to assess the side effects of the drug as compared to placebo; the Fatigue Severity Scale, SF-36, GSQ-30, and PROMIS-29 questionnaires to assess physical functioning, general health, vitality, social functioning, bodily pain, role physical, role emotional, mental health, symptoms, fatigue, anxiety, depression, and sleep disturbances; the CSSRS to assess suicidal ideation.

At the 6-month mark, the study will be unblinded and participants in the placebo group will be invited to repeat the study visits receiving Ceftriaxone. Participants who originally received Ceftriaxone will receive a phone call follow up at 1 year. The duration for both groups is one year. Samples will be collected for safety labs and research assessments.

Connect with a study center

  • SUNY Upstate Medical University, Upstate Global Health Institute

    East Syracuse, New York 13057
    United States

    Active - Recruiting

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