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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. Identifier: NCT00000937
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Lyme Disease Drug: Antibiotics Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Study and Treatment of Post Lyme Disease (STOP-LD)
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000937

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United States, New York
Lauren Krupp
Stony Brook, New York, United States, 117948121
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Layout table for additonal information Identifier: NCT00000937    
Other Study ID Numbers: DMID 96-182
R01AI031561-04A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: November 2005
Additional relevant MeSH terms:
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Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Anti-Bacterial Agents
Anti-Infective Agents