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Anti-bacterial
Ceftriaxone for Chronic Lyme Disease
Phase < 1
Recruiting
Led By Kristopher Paolino, MD
Research Sponsored by State University of New York - Upstate Medical University
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 1 year post study start
Summary
"This trial aims to see if giving the FDA approved drug Ceftriaxone every 5 days for 6 weeks can help people aged 18-75 with persistent Lyme disease symptoms after completing
Who is the study for?
This trial is for adults aged 18-75 who have had Lyme disease and are still feeling sick after treatment. They must be able to come to the clinic every 5-6 days for an IV infusion and answer health questions.
What is being tested?
The study tests if Ceftriaxone, given every five days over six weeks, is safe and can improve symptoms of persistent Lyme disease compared to a placebo (a substance with no drug).
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues like diarrhea or nausea, changes in blood cell counts, or liver enzyme alterations. Regular blood tests will monitor these.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience fatigue that affects my daily activities.
Select...
I haven't taken antibiotics for Lyme disease in the last 6 weeks and can avoid them during the study.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Select...
I have had a Clostridium difficile infection before.
Select...
I have had symptoms related to Lyme disease for over 10 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post study start
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of Abnormal Laboratory Measurements
Duration of adverse events
Intensity adverse events
+4 moreSecondary study objectives
Fatigue Severity Scale
General Symptom Questionnaire
Lyme VlsE1/pepC10 Antibody
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: CeftriaxoneActive Control1 Intervention
Participants will receive IV infusion of 2g Ceftriaxone, approximately every 5 days for 6 weeks for a total of 9 treatments.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive IV infusion of dextrose 5% in water, approximately every 5 days for 6 weeks for a total of 9 treatments
Find a Location
Who is running the clinical trial?
State University of New York - Upstate Medical UniversityLead Sponsor
174 Previous Clinical Trials
27,426 Total Patients Enrolled
Steven & Alexandra Cohen FoundationOTHER
9 Previous Clinical Trials
274 Total Patients Enrolled
3 Trials studying Lyme Disease
90 Patients Enrolled for Lyme Disease
Kristopher Paolino, MDPrincipal InvestigatorState University of New York - Upstate Medical University
2 Previous Clinical Trials
157 Total Patients Enrolled