MedTrace Logo

Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

NCT06611111 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-03-19

No results posted yet for this 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.

Conditions

  • Post-Treatment Lyme Disease

Interventions

DRUG

Ceftriaxone (Rocephin®)

Slightly yellow liquid.

DRUG

Dextrose 5% (D5W)

Colorless liquid

Sponsors & Collaborators

  • Steven & Alexandra Cohen Foundation

    collaborator OTHER

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Kristopher Paolino, MD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611111 on ClinicalTrials.gov