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NCT06611111 · ClinicalTrials.gov registry record · Early Phase 1
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
A Early Phase 1 study of Post-Treatment Lyme Disease, sponsored by State University of New York - Upstate Medical University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT06611111: Recruiting Early Phase 1 study of Post-Treatment Lyme Disease, sponsored by State University of New York - Upstate Medical University.
NCT06611111 is a Early Phase 1 study of Post-Treatment Lyme Disease that is actively recruiting participants, run by State University of New York - Upstate Medical University. The registered enrollment target is 44 participants, roughly in line with the 48-participant average among 4 other Post-Treatment Lyme Disease trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06611111, a Early Phase 1 study of Post-Treatment Lyme Disease, is actively recruiting participants, sponsored by State University of New York - Upstate Medical University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
Total number of all abnormal labs
Conditions Studied
Interventions
- DRUG Ceftriaxone (Rocephin®)
- DRUG Dextrose 5% (D5W)
Study Locations (1)
New York
- SUNY Upstate Medical University, Upstate Global Health Institute - East Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What NCT06611111 shows while recruiting
NCT06611111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, roughly in line with the 48-participant average among 4 other Post-Treatment Lyme Disease trials with a reported enrollment target.
The record links to 1 condition, with Post-Treatment Lyme Disease appearing as the primary indexed condition, and to 2 interventions - of which Ceftriaxone (Rocephin®) is the first listed.
NCT06611111 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06611111 about?
NCT06611111 is a clinical study titled "Ceftriaxone Pulse Dose 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 ...
What is the current status of trial NCT06611111?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 44 participants. The study started on 2025-02-03. Estimated completion is 2026-12.
What conditions does trial NCT06611111 study?
This clinical trial studies the following conditions: Post-Treatment Lyme Disease.
What interventions are being tested in trial NCT06611111?
The interventions under investigation include: Ceftriaxone (Rocephin®) (DRUG), Dextrose 5% (D5W) (DRUG).
Who is sponsoring clinical trial NCT06611111?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06611111 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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