RECRUITING

Ceftriaxone for Post-Treatment Lyme Disease

Conditions

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

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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

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.

Official Title

Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease

Quick Facts

Study Start:2025-09-15

Study Completion:2026-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06785402

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
* 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.	* 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. * 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) * 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) * 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

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.
* 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)
* 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)
* 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

Contacts and Locations

Study Contact

Bindu Balani, MD

CONTACT

201 487 - 4088

bindu.balani@hmhn.org

Nicole AlMallah

CONTACT

nicole.almallah@hmhn.org

Principal Investigator

Bindu Balani, MD

PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Study Locations (Sites)

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Collaborators and Investigators

Sponsor: Hackensack Meridian Health

Bindu Balani, MD, PRINCIPAL_INVESTIGATOR, Hackensack Meridian Health

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 Date2025-09-15

Study Completion Date2026-08-01

Study Record Updates

Study Start Date2025-09-15

Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Post-Treatment Lyme Disease Syndrome