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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• ClinicalTrials.gov Identifier: NCT00000937
• Other Study ID Numbers: DMID 96-182; R01AI031561-04A1 ( U.S. NIH Grant/Contract )
• First Posted: August 31, 2001
• Last Update Posted: August 27, 2010
• Last Verified: November 2005

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