Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

NCT06611111 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2024-02-UMU
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Treatment Lyme Disease

Keywords

Pulse Dose; Ceftriaxone; PTLDS; Chronic Lyme Disease

Outcome Measures

Primary Outcomes (7)

• Number of abnormal laboratory measurements

  Total number of all abnormal labs

  30 days post last treatment

• Intensity of Abnormal Laboratory Measurements

  Graded according clinical laboratory normals and FDA toxicity scale

  30 days post final treatment

• Duration of Abnormal Laboratory Measurements

  Number of days of abnormal lab

  30 days post final treatment

• Occurrence of adverse events

  Total number of adverse events

  30 days post last treatment

• Intensity adverse events

  Graded according FDA toxicity scale

  30 days post final treatment

• Duration of adverse events

  Number of days per adverse event

  30 days post final treatment

• Number of serious adverse events

  Total number

  1 year post study start

Secondary Outcomes (7)

• Fatigue Severity Scale

  At 6 and 12 months

• SAFTEE assessment

  1 month post last dose

• SF-36 continuous variables

  6 and 12 months

• SF-36 Responder-Nonresponder

  6 and 12 months

• General Symptom Questionnaire

  6 and 12 months

Study Arms (2)

Ceftriaxone

ACTIVE COMPARATOR

Participants will receive IV infusion of 2g Ceftriaxone, approximately every 5 days for 6 weeks for a total of 9 treatments.

Drug: Ceftriaxone (Rocephin®)

Placebo

PLACEBO COMPARATOR

Participants will receive IV infusion of dextrose 5% in water, approximately every 5 days for 6 weeks for a total of 9 treatments

Drug: Dextrose 5% (D5W)

Interventions

Ceftriaxone (Rocephin®) DRUG

Slightly yellow liquid.

Ceftriaxone

Dextrose 5% (D5W) DRUG

Colorless liquid

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety
• \. 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

Sponsors & Collaborators

• Steven & Alexandra Cohen Foundation: collaborator
• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University, Upstate Global Health Institute

East Syracuse, New York, 13057, United States

RECRUITING

MeSH Terms

Conditions

Post-Lyme Disease Syndrome

Interventions

Ceftriaxone; Glucose

Condition Hierarchy (Ancestors)

Lyme Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Kristopher Paolino, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keely Terrillion

CONTACT

315-464-9869; trials@upstate.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who meet inclusion/exclusion criteria will be randomized 1:1 into receiving ceftriaxone or placebo. At day 181, the study will be unblinded and participants in the placebo group will be invited to receive ceftriaxone on the same schedule.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be shared with the primary publication.
• Access Criteria: Primary IPD will be published with the primary manuscript describing the study. Requests for additional information can be requested by emailing warel@upstate.edu.

Locations

US (1)