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

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000937

Purpose

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 III

MedlinePlus related topics: Antibiotics Lyme Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study and Treatment of Post Lyme Disease (STOP-LD)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000937

Locations

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

Study ID Numbers:	DMID 96-182, R01 AI 31561-04A1
Study First Received:	November 2, 1999
Last Updated:	November 11, 2005
ClinicalTrials.gov Identifier:	NCT00000937
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Bacterial Infections
Borrelia Infections
Borreliosis

Lyme Disease
Tick-Borne Diseases
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Spirochaetales Infections

ClinicalTrials.gov processed this record on January 15, 2009