Study and Treatment of Post Lyme Disease (STOP-LD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Study and Treatment of Post Lyme Disease (STOP-LD)|
|Estimated Study Completion Date:||November 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000937
|United States, New York|
|Stony Brook, New York, United States, 117948121|