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Anti-bacterial

Ceftriaxone for Lyme Disease

Hackensack, NJ

Phase 1 & 2

Waitlist Available

Led By Bindu Balani, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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.

Must not have

Female: pregnant or lactating

Prior history of Clostridium difficile infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post treatment initiation

Summary

This trial aims to study whether giving Ceftriaxone every 5 days for about 6 weeks can kill the organism that causes persistent Lyme infection. Participants will be randomly assigned to receive either

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Who is the study for?

This trial is for individuals who have been treated for Lyme disease but continue to experience symptoms, suggesting Post-Treatment Lyme Disease Syndrome (PTLDS). Participants must be able to commit to a 6-week treatment plan with follow-ups extending up to 12 months.Check my eligibility

What is being tested?

The study is testing the effectiveness of Ceftriaxone, an antibiotic, given every five days over six weeks against a placebo. Patients are randomly assigned in equal numbers and will not know which group they're in until after six months.See study design

What are the potential side effects?

Ceftriaxone may cause side effects such as allergic reactions, gastrointestinal discomfort, changes in blood cell counts or liver enzymes, and possible infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience fatigue that affects my daily activities.

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I haven't taken antibiotics for Lyme disease in the last 6 weeks and won't take any during the study.

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I am between 18 and 75 years old.

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I had Lyme disease before and now have persistent symptoms.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have had a Clostridium difficile infection before.

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I have had symptoms related to Lyme disease for over 10 years.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post treatment initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post treatment initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of pulse-dosed ceftriaxone

Study Feasibility

Tolerability of pulse-dosed ceftriaxone

Secondary study objectives

Clinical Improvement - General Symptom Questionnaire (GSQ-30)

Clinical Improvement - PROMIS-29

Clinical Improvement - Physical and mental summary indices

+1 more

Side effects data

From 2022 Phase 4 trial • 42 Patients • NCT05027516

pain at injection site

100%

80%

60%

40%

20%

Study treatment Arm

Rocephine®

Rocephine® + Azithromycin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ceftriaxone 2 GMExperimental Treatment1 Intervention

Administration of IV ceftriaxone or D5W. Subjects will be infused approximately every 5 days (+/- 1 day) over the course of \~6 weeks. Subjects will receive a total of 9 infusions throughout the treatment phase of the study, with the last infusion tentatively scheduled for Day 41 (+/- 3 days).

Group II: PlaceboPlacebo Group1 Intervention

Placebo \[dextrose (5% in water), (D5W)\] IV following the same infusion schedule as the ceftriaxone arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceftriaxone treatment

2012

Completed Phase 4

~200

0 / 7Eligibility criteria met