Could a 'Pulse' of antibiotics ease Long-Term lyme symptoms?

NCT ID NCT06611111

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests whether giving the antibiotic ceftriaxone every 5 days for 6 weeks can safely reduce persistent symptoms like fatigue and pain in people who have already been treated for Lyme disease. About 44 adults aged 18 to 75 will receive either the drug or a placebo by IV. The main goal is to check safety and tolerability, with a secondary look at symptom improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ceftriaxone (an antibiotic)
What this could lead to
If it works, this could point toward a new way to ease lingering symptoms like fatigue and pain in people who have already been treated for Lyme disease.
What could go wrong
This is a very early, small Phase 1 trial focused on safety, not effectiveness. The drug may not improve symptoms, and side effects from repeated IV infusions are possible.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 to 75 at the time of consent 2. Ability and willingness to sign informed consent 3. Available for the study period 4. Must have met the definition of a prior well-defined or probable Lyme disease infection, AND meet the definition of PTLDS 5. Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit 6. 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) 7. 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. Exclusion Criteria: 1. Female: pregnant or lactating 2. Women who intend to become pregnant during the treatment study period (approximately 45 days) 3. Patients with a diagnosis of Lyme disease based on only a positive Lyme IgM immunoblot 4. A history of cephalosporin allergy or significant intolerance 5. Lyme related symptoms that have been present for greater than 10 years 6. 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. 7. 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 8. 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 9. 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) 10. 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) 11. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety 12. 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 13. Prior history of Clostridium difficile infection 14. Currently taking warfarin (Coumadin) 15. Unable to comply with study requirements 16. Clinician discretion

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Conditions

The condition(s) this trial relates to.

Post-Lyme Disease Syndrome post-treatment Lyme disease syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • SUNY Upstate Medical University, Upstate Global Health Institute

    RECRUITING

    East Syracuse, New York, 13057, United States

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