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

This study has been completed.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: November 2, 1999
Last updated: August 26, 2010
Last verified: November 2005
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 Intervention Phase
Lyme Disease Drug: Antibiotics Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Study and Treatment of Post Lyme Disease (STOP-LD)

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 55
Estimated Study Completion Date: November 2005
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.

Ages Eligible for Study:   18 Years to 65 Years   (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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00000937

United States, New York
Lauren Krupp
Stony Brook, New York, United States, 117948121
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information Identifier: NCT00000937     History of Changes
Other Study ID Numbers: DMID 96-182
R01AI031561-04A1 ( U.S. NIH Grant/Contract )
Study First Received: November 2, 1999
Last Updated: August 26, 2010

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017