Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000937
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
1999-11-02
Brief Title:
Study and Treatment of Post Lyme Disease STOP-LD
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Study and Treatment of Post Lyme Disease STOP-LD
Status:
COMPLETED
Status Verified Date:
2005-11
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:
The purpose of this study is to see how well antibiotics work in reducing chronic fatigue symptoms such as tiredness in patients that were treated for Lyme Disease Fatigue is a common symptom of Lyme Disease When fatigue does not improve after treatment patients are considered to have Post Lyme Syndrome PLS The chronic fatigue seen in these patients appears to be related to the initial infection which causes Lyme Disease It is believed but not proven that treatment with antibiotics may be effective in relieving chronic fatigue in PLS patients
Detailed Description:
You will be assigned randomly like tossing a coin to receive either antibiotics or a placebo sugar pill Neither you nor your doctor will know which you are receiving You will learn to give yourself the injection and you will remain on your study drug for 28 days A home health care nurse will visit you twice a week to check the injection site and at weeks 1 and 3 the nurse will draw blood for laboratory tests At months 1 and 6 you will be examined to see if you have fewer chronic fatigue symptoms after the antibiotics This will include a fatigue questionnaire a test of your mental processing speed and a test of your cerebrospinal fluid
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI031561-04A1 | NIH | None | httpsreporternihgovquickSearchR01AI031561-04A1 |