Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611111
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Randomized Double-Blind Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This study will explore treating participants who are 18 to 75 years old with Post-Treatment Lyme Disease IV Ceftriaxone will be delivered in a pulse dose fashion approximately every 5 days for a total of 9 IV infusions over 6 weeks Participants will return one month following last treatment at approximately 3 and 6 months from study start At each study visit participants will be asked a number of questionnaires including the SAFTEE assessment to assess the side effects of the drug as compared to placebo the Fatigue Severity Scale SF-36 GSQ-30 and PROMIS-29 questionnaires to assess physical functioning general health vitality social functioning bodily pain role physical role emotional mental health symptoms fatigue anxiety depression and sleep disturbances the CSSRS to assess suicidal ideation
At the 6-month mark the study will be unblinded and participants in the placebo group will be invited to repeat the study visits receiving Ceftriaxone Participants who originally received Ceftriaxone will receive a phone call follow up at 1 year The duration for both groups is one year Samples will be collected for safety labs and research assessments
At the 6-month mark the study will be unblinded and participants in the placebo group will be invited to repeat the study visits receiving Ceftriaxone Participants who originally received Ceftriaxone will receive a phone call follow up at 1 year The duration for both groups is one year Samples will be collected for safety labs and research assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None