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

Primary Purpose

Lyme Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Antibiotics
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lyme Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Lauren Krupp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000937
Brief Title
Study and Treatment of Post Lyme Disease (STOP-LD)
Official Title
Study and Treatment of Post Lyme Disease (STOP-LD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
55 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Antibiotics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Lauren Krupp
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948121
Country
United States

12. IPD Sharing Statement

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

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