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New treatment option for Post-Treatment Lyme Disease
Official title Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
ClinicalTrials.gov ID: NCT06611111
What this study is testing
What is Ceftriaxone (Rocephin®)?
Ceftriaxone (Rocephin®) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post-treatment lyme disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 1: an early, usually small safety study
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join 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: people who...
See the full eligibility criteria
- 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)
- people 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...
- 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: people who have well controlled HIV, who are on ART with a CD4 count greater than...
- 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...
- 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...
- 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...
- 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...
- 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...
- Prior history of Clostridium difficile infection
- Currently taking warfarin (Coumadin)
- Unable to comply with study requirements
- Clinician discretion
The study team makes the final eligibility decision.
Where it's taking place
- East Syracuse, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include East Syracuse, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.