Post-Treatment Lyme Disease SyndromePhase 1/2NCT06785402
Ceftriaxone for Post-Treatment Lyme Disease
A Phase 1/2 study testing Ceftriaxone treatment in people with Post-Treatment Lyme Disease Syndrome, run by Hackensack Meridian Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Treatment Lyme Disease Syndrome
- What is being tested?
- Ceftriaxone treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 14 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
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
- Being tested
- Ceftriaxone treatment, Placebo
- Keywords
- Post-Treatment Lyme disease Syndrome (PTLDS), Ceftriaxone, Persistent Symptoms
- Medical subject headings
- Post-Lyme Disease Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone treatmentDrug
9 infusions spaced out approximately every 5 days
PlaceboDrug
D5W (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Ceftriaxone treatment |
| Placebo | Placebo comparator | Placebo [dextrose (5% in water), (D5W)] IV following the same infusion schedule as the ceftriaxone arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months post treatment initiation
Study Feasibility
To assess the recruit the patients within the pre-determined period of time (6 months).
Measured: 6 month enrollment period
Secondary outcomes (4)
Clinical Improvement - Physical and mental summary indices
To assess clinical improvement after treatment using additional clinical outcome measures. Primary functional change with the physical and mental summary indices of the SF-36 as either responder or non-responder (a change of 6.5 points on the SF-physical health summary scale, and 7.9 points on the mental health summary scale respectively). Eight scales are used and when combined measure the physical and mental health of participants. Each scale is scored to have same average (50) and the same standard deviation (10 points). with a score below 50 representing below average health.
Measured: 12 months post treatment initiation
Clinical Improvement - General Symptom Questionnaire (GSQ-30)
To assess clinical improvement after treatment using additional clinical outcome measures. General Symptom Questionnaire (GSQ-30).GSQ-30 us used to assess symptom burden and specifically pain/fatigue, neuropsychiatric, neurologic, and viral-like symptom burden impacting function. Each symptom is measured on scale of 0 (not at all) to 4 (very much) for an overall score of 0-120 with higher scores representing higher burden.
Measured: 12 months post treatment initiation
Clinical Improvement - PROMIS-29
To assess clinical improvement after treatment using additional clinical outcome measures using PROMIS-29 which has multiple sections and scoring varies by section.
The min/max are as follows: Physical Function (PF) 4-20, Anxiety 4-20, Depression 4-20, Fatigue 4-20, Sleep Disturbance- 4-20, Ability to Participate in Social Roles and Activities (APSRA) 4-20, Pain Interference 4-20, Pain Intensity 0-10.
For PF and APSRA, improvement would be tracked by an increase in score. For Anxiety, Depression, Fatigue, Sleep Disturbance, Pain interference, and Pain Intensity improvement would be tracked by a decrease in score.
A higher score in PF and APSRA suggest better health. A higher score in Anxiety, Depression, Fatigue, Sleep Disturbance, Pain interference and Pain Intensity suggests lower health.
A score change of 5 points or more is considered clinically meaningful.
Measured: 12 months post treatment initiation
Clinical Improvement - Quantitative Lyme VlsE1/pepC10 Ab
To assess clinical improvement after treatment using additional clinical outcome measures changes in quantitative Lyme VlsE1/pepC10 Ab. Higher titers represent higher antibodies.
Measured: 12 months post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start14 May 2026 (estimated)
- Primary completion14 May 2026
- Study completion14 May 2026
Why it stopped: Enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Treatment Lyme Disease SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia Clinical Trials Network for Lyme and Other Tick-Borne Diseases
- Responsible party
- Sponsor
- Investigators
- Bindu Balani, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785402
- Sponsor's protocol ID
- Pro2024-0373
- Status last verified
- May 2026
- First submitted
- 16 Jan 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
- ClinicalTrials.gov ID
- NCT06785402
- Acronym / sponsor ID
- Pro2024-0373
- Conditions
- Post-Treatment Lyme Disease Syndrome
- Keywords
- Post-Treatment Lyme disease Syndrome (PTLDS), Ceftriaxone, Persistent Symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Columbia Clinical Trials Network for Lyme and Other Tick-Borne Diseases
- Study start
- 14 May 2026 (estimated)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone 2 GM | Experimental | Drug: Ceftriaxone treatmentAdministration 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). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo [dextrose (5% in water), (D5W)] IV following the same infusion schedule as the ceftriaxone arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftriaxone treatment9 infusions spaced out approximately every 5 days | Drug | Ceftriaxone 2 GM |
| PlaceboD5W (placebo) | Drug | Placebo |
Primary outcome
Safety of pulse-dosed ceftriaxone
Time frame: 12 months post treatment initiation
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.
Tolerability of pulse-dosed ceftriaxone
Time frame: 12 months post treatment initiation
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.
Study Feasibility
Time frame: 6 month enrollment period
To assess the recruit the patients within the pre-determined period of time (6 months).
4 secondary outcomes
Clinical Improvement - Physical and mental summary indices
Time frame: 12 months post treatment initiation
Clinical Improvement - General Symptom Questionnaire (GSQ-30)
Time frame: 12 months post treatment initiation
Clinical Improvement - PROMIS-29
Time frame: 12 months post treatment initiation
Clinical Improvement - Quantitative Lyme VlsE1/pepC10 Ab
Time frame: 12 months post treatment initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Post-Treatment Lyme Disease Syndrome
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Lyme Disease
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
RecruitingObservational study
Navigating Pregnancy and Parenthood With Lyme Disease
Lyme Disease, Post Treatment Lyme Disease
RecruitingObservational study
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Lyme Disease, Post-Treatment Lyme Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bindu Balani, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ceftriaxone treatment in people with Post-Treatment Lyme Disease Syndrome, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of pulse-dosed ceftriaxone (time frame: 12 months post treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.