Post-Treatment Lyme DiseaseEarly Phase 1NCT06611111
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
A Early Phase 1 study testing Ceftriaxone (Rocephin®) and Dextrose 5% (D5W) in people with Post-Treatment Lyme Disease, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Treatment Lyme Disease
- What is being tested?
- Ceftriaxone (Rocephin®) and Dextrose 5% (D5W)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
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.
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- 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)
- 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
- 12. 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
- Clinician discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SUNY Upstate Medical University, Upstate Global Health Institute
East Syracuse, New York, 13057
About this study
Official title: Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
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?
Read more
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.
Read the detailed 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.
- Conditions
- Post-Treatment Lyme Disease
- Being tested
- Ceftriaxone (Rocephin®), Dextrose 5% (D5W)
- Keywords
- Pulse Dose, Ceftriaxone, PTLDS, Chronic Lyme Disease
- 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 (Rocephin®)Drug
Slightly yellow liquid.
Dextrose 5% (D5W)Drug
Colorless liquid
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone | Active comparator | Participants will receive IV infusion of 2g Ceftriaxone, approximately every 5 days for 6 weeks for a total of 9 treatments. Receives: 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 Receives: Drug: Dextrose 5% (D5W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of abnormal laboratory measurements
Total number of all abnormal labs
Measured: 30 days post last treatment
Intensity of Abnormal Laboratory Measurements
Graded according clinical laboratory normals and FDA toxicity scale
Measured: 30 days post final treatment
Duration of Abnormal Laboratory Measurements
Number of days of abnormal lab
Measured: 30 days post final treatment
Occurrence of adverse events
Total number of adverse events
Measured: 30 days post last treatment
Intensity adverse events
Graded according FDA toxicity scale
Measured: 30 days post final treatment
Duration of adverse events
Number of days per adverse event
Measured: 30 days post final treatment
Number of serious adverse events
Total number
Measured: 1 year post study start
Secondary outcomes (7)
Fatigue Severity Scale
Clinical improvement
Measured: At 6 and 12 months
SAFTEE assessment
Adverse events
Measured: 1 month post last dose
SF-36 continuous variables
Primary functional change with physical and mental summary indices as continuous variables.
Measured: 6 and 12 months
SF-36 Responder-Nonresponder
Primary functional change with the physical and mental summary indices as either responder or nonresponder.
Measured: 6 and 12 months
General Symptom Questionnaire
Changes in secondary clinical outcomes
Measured: 6 and 12 months
PROMIS-29
Changes in secondary clinical outcomes
Measured: 6 and 12 months
Lyme VlsE1/pepC10 Antibody
Changes in quantitative antibody levels
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start3 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Treatment Lyme DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Steven & Alexandra Cohen Foundation
- Responsible party
- Sponsor
- Investigators
- Kristopher Paolino, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611111
- Sponsor's protocol ID
- 2024-02-UMU
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies the primary results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
- ClinicalTrials.gov ID
- NCT06611111
- Acronym / sponsor ID
- 2024-02-UMU
- Conditions
- Post-Treatment Lyme Disease
- Keywords
- Pulse Dose, Ceftriaxone, PTLDS, Chronic Lyme Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Steven & Alexandra Cohen Foundation
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Sep 2024 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone | Active comparator | Drug: Ceftriaxone (Rocephin®)Participants will receive IV infusion of 2g Ceftriaxone, approximately every 5 days for 6 weeks for a total of 9 treatments. |
| Placebo | Placebo comparator | Drug: Dextrose 5% (D5W)Participants will receive IV infusion of dextrose 5% in water, approximately every 5 days for 6 weeks for a total of 9 treatments |
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 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
Key exclusion criteria (17 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 (Rocephin®)Slightly yellow liquid. | Drug | Ceftriaxone |
| Dextrose 5% (D5W)Colorless liquid | Drug | Placebo |
Primary outcome
Number of abnormal laboratory measurements
Time frame: 30 days post last treatment
Total number of all abnormal labs
Intensity of Abnormal Laboratory Measurements
Time frame: 30 days post final treatment
Graded according clinical laboratory normals and FDA toxicity scale
Duration of Abnormal Laboratory Measurements
Time frame: 30 days post final treatment
Number of days of abnormal lab
Occurrence of adverse events
Time frame: 30 days post last treatment
Total number of adverse events
Intensity adverse events
Time frame: 30 days post final treatment
Graded according FDA toxicity scale
Duration of adverse events
Time frame: 30 days post final treatment
Number of days per adverse event
Number of serious adverse events
Time frame: 1 year post study start
Total number
7 secondary outcomes
Fatigue Severity Scale
Time frame: At 6 and 12 months
SAFTEE assessment
Time frame: 1 month post last dose
SF-36 continuous variables
Time frame: 6 and 12 months
SF-36 Responder-Nonresponder
Time frame: 6 and 12 months
General Symptom Questionnaire
Time frame: 6 and 12 months
PROMIS-29
Time frame: 6 and 12 months
Lyme VlsE1/pepC10 Antibody
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlies the primary results in a publication.
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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.
Kristopher Paolino, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ceftriaxone (Rocephin®) and Dextrose 5% (D5W) in people with Post-Treatment Lyme Disease, run by State University of New York - Upstate Medical University 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 17 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: looking for participants now, as of the sponsor's last update on 19 Mar 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keely Terrillion (315-464-9869, trials@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of abnormal laboratory measurements (time frame: 30 days post last treatment). The study lists 7 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 19 Mar 2026.