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

NCT00000937 | Completed Phase 3

• 2 other identifiers: DMID 96-182R01AI031561-04A1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Disease

Interventions

Antibiotics DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Lauren Krupp

Stony Brook, New York, 117948121, United States

Location

MeSH Terms

Conditions

Lyme Disease

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: November 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2005-11

Locations

US (1)