Ceftriaxone for Post-Treatment Lyme Disease

NCT06785402 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro2024-0373
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Lyme disease is a public health crisis in the US. It is estimated that over 400,000 cases occur every year with 10-20% of those infected going on to develop Post-Treatment Lyme disease Syndrome (PTLDS). The goal of this study is to investigate if giving Ceftriaxone every 5 days for about 6 weeks kills the organism that produces persistent Lyme infection. Enrolled participants will be randomized 1:1 receiving either pulse-dosed ceftriaxone or placebo \[dextrose (5% in water), (D5W)\], intravenously. Participants will be evaluated at each of the study visits, and then in a follow-up phase out to 12 months. They will be unblinded at 6 months and those randomized to the placebo group will be offered pulse-dosed ceftriaxone on the same schedule as those randomized to the drug group. All patients will be followed up for a total of 12 months post treatment initiation.

Conditions

Post-Treatment Lyme Disease Syndrome

Keywords

Post-Treatment Lyme disease Syndrome (PTLDS); Ceftriaxone; Persistent Symptoms

Outcome Measures

Primary Outcomes (3)

• Safety of pulse-dosed ceftriaxone

  To assess the safety of pulse-dosed ceftriaxone in PTLDS when compared to placebo as well as historical data based on the number of reported adverse and serious adverse events.

  12 months post treatment initiation

• Tolerability of pulse-dosed ceftriaxone

  To assess the tolerability of pulse-dosed ceftriaxone in PTLDS when compared to placebo as well as historical data based on the number of reported adverse and serious adverse events.

  12 months post treatment initiation

• Study Feasibility

  To assess the recruit the patients within the pre-determined period of time (6 months).

  6 month enrollment period

Secondary Outcomes (4)

• Clinical Improvement - Physical and mental summary indices

  12 months post treatment initiation

• Clinical Improvement - General Symptom Questionnaire (GSQ-30)

  12 months post treatment initiation

• Clinical Improvement - PROMIS-29

  12 months post treatment initiation

• Clinical Improvement - Quantitative Lyme VlsE1/pepC10 Ab

  12 months post treatment initiation

Study Arms (2)

Ceftriaxone 2 GM

EXPERIMENTAL

Administration of IV ceftriaxone or D5W. Subjects will be infused approximately every 5 days (+/- 1 day) over the course of \~6 weeks. Subjects will receive a total of 9 infusions throughout the treatment phase of the study, with the last infusion tentatively scheduled for Day 41 (+/- 3 days).

Drug: Ceftriaxone treatment

Placebo

PLACEBO COMPARATOR

Placebo \[dextrose (5% in water), (D5W)\] IV following the same infusion schedule as the ceftriaxone arm.

Drug: Placebo

Interventions

Placebo DRUG

D5W (placebo)

Placebo

Ceftriaxone treatment DRUG

9 infusions spaced out approximately every 5 days

Ceftriaxone 2 GM

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 years 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 and photographs 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 of \>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 per the CSSRS scale (score 6 or greater), 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 erythematosus, 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 or during the trial
• Prior history of Clostridium difficile infection
• Unable to comply with study requirements
• Clinician discretion

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Columbia Clinical Trials Network for Lyme and Other Tick-Borne Diseases: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

MeSH Terms

Conditions

Post-Lyme Disease Syndrome

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

Study Officials

• Bindu Balani, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bindu Balani, MD

CONTACT

201 487 - 4088; bindu.balani@hmhn.org

Nicole AlMallah

CONTACT

nicole.almallah@hmhn.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and the study team will be blinded. The research pharmacist will be the unblinded party.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled subjects will be randomized 1:1 receiving either pulse-dosed ceftriaxone or placebo \[dextrose (5% in water), (D5W)\], intravenously. Subjects will be follow-up phase out to 12 months. Subjects will be unblinded at 6 months and those randomized to the placebo group will be offered pulse-dosed ceftriaxone on the same schedule as those randomized to the drug group. All subjects will be followed up for a total of 12 months post treatment initiation.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)