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RECRUITING
NCT06785402
PHASE1/PHASE2

Ceftriaxone for Post-Treatment Lyme Disease

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

Summary

Lyme disease is a public health crisis in the US. It is estimated that over 400,000 cases occur every year with 10-20% of those infected going on to develop Post-Treatment Lyme disease Syndrome (PTLDS). The goal of this study is to investigate if giving Ceftriaxone every 5 days for about 6 weeks kills the organism that produces persistent Lyme infection. Enrolled participants will be randomized 1:1 receiving either pulse-dosed ceftriaxone or placebo \[dextrose (5% in water), (D5W)\], intravenously. Participants will be evaluated at each of the study visits, and then in a follow-up phase out to 12 months. They will be unblinded at 6 months and those randomized to the placebo group will be offered pulse-dosed ceftriaxone on the same schedule as those randomized to the drug group. All patients will be followed up for a total of 12 months post treatment initiation.

Official title: Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-15

Completion Date

2027-12-01

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Ceftriaxone treatment

9 infusions spaced out approximately every 5 days

DRUG

Placebo

D5W (placebo)

Locations (1)

Hackensack University Medical Center

Hackensack, New Jersey, United States