Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001101
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
1999-11-02
Brief Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lyme disease is the most common tick-borne disease in the United States It is caused by the spirochete Borrelia burgdorferi It may exist in a chronic form and be the result of 1 active infection by B burgdorferi 2 damage caused by the original infectious process or 3 the presence of co-infection with another organism transmitted by Ixodes ticks The purpose of this study is to determine the safety and effectiveness for seropositive patients of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease CLD
Detailed Description:
One hundred ninety-four 194 patients will be enrolled in this study Each patient will be assigned to one of two groups and will be randomly selected to receive either antibiotic therapy or placebo but the assignment of medication will not be made known to the patient or administering doctor Antibiotic or placebo will be given intravenously IV for 30 consecutive days and then orally for the next 60 consecutive days
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: