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Trial record 18 of 64 for:    lyme

Study and Treatment of Post Lyme Disease (STOP-LD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000937
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:

November 2, 1999
August 31, 2001
August 27, 2010
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Complete list of historical versions of study NCT00000937 on ClinicalTrials.gov Archive Site
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Study and Treatment of Post Lyme Disease (STOP-LD)
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Lyme Disease
Drug: Antibiotics
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
November 2005
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Inclusion Criteria:

You may be eligible for this study if you:

  • Are between 18 and 65 years of age.
  • Are a resident of Long Island or greater NY metropolitan area.
  • Are fluent in English.
  • Have a history of Lyme Disease.
  • Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study.
  • Have severe fatigue.
  • Are not pregnant or planning to be pregnant.

Exclusion Criteria:

You will not be eligible for this study if you:

  • Have or have had major medical, neurologic, or psychiatric disorder.
  • Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease.
  • Have had Fibromyalgia Syndrome.
  • Have a history of sleep apnea, narcolepsy, or other serious sleep disorder.
  • Have a learning disability.
  • Have had head trauma requiring hospitalization.
  • Have symptomatic gallbladder disease.
  • Are anemic.
  • Abuse alcohol or illicit drugs.
  • Have been treated with another antimicrobial agent for Lyme Disease within 6 months of study.
  • Need to be receiving systemic steroid therapy during drug administration and follow-up.
  • Have used benzodiazepines within 1 month of study entry.
  • Are allergic to Beta lactams (a class of antibiotics).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000937
DMID 96-182
R01AI031561-04A1 ( U.S. NIH Grant/Contract )
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP