- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000938
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease
August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Lyme disease is the most common tick-borne disease in the United States.
It is caused by the spirochete Borrelia burgdorferi.
It may exist in a chronic form and be the result of: 1) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks.
The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sixty-six patients will be enrolled in this study.
Each patient will be assigned to one of two groups and will be randomly selected to receive either antibiotic therapy or placebo; but, the assignment of medication will not be made known to the patient or administering doctor.
Antibiotic or placebo will be given intravenously (IV) for 30 consecutive days and then orally for the next 60 consecutive days.
Study Type
Interventional
Enrollment
66
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Mark Klempner
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
You may be eligible for this study if you:
- Are at least 18 years of age.
- Are seronegative for antibodies against B. burgdorferi antigens by Western Blot at enrollment.
- Have documented history of acute Lyme disease.
- Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer, or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia.
- Have had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary)
- Have had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain, beginning within 6 months following initial infection with B. burgdorferi.
- Have had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen.
Exclusion Criteria:
You will not be eligible for this study if you:
- Have previously enrolled in this study.
- Are pregnant, lactating, or unable to use birth control measures during the treatment period of this study.
- Are taking chronic medication that could interfere with evaluation of symptoms.
- Are taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary).
- Are hypersensitive to ceftriaxone or doxycycline.
- Have active inflammatory synovitis.
- Have another disease that could account for symptoms of acute Lyme disease.
- Have another serious or active infection.
- Are unable to tolerate an IV.
- Have tested positive for Borrelia DNA in plasma or cerebrospinal fluid at the time of initial evaluation for study.
- Have tested seropositive by Western Blot (these patients may be offered enrollment in seropositive study).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 26, 2010
Last Verified
November 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Tick-Borne Diseases
- Borrelia Infections
- Spirochaetales Infections
- Lyme Disease
- Post-Lyme Disease Syndrome
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Ceftriaxone
- Doxycycline
Other Study ID Numbers
- DMID 97-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lyme Disease
-
Johns Hopkins UniversitySteven and Alexandra Cohen FoundationEnrolling by invitationPost-Treatment Lyme Disease | Chronic Lyme Disease | Lyme Disease, ChronicUnited States
-
Research Foundation for Mental Hygiene, Inc.WithdrawnPost-Treatment Lyme Disease
-
Research Foundation for Mental Hygiene, Inc.TerminatedPost Treatment Lyme Disease SyndromeUnited States
-
ProgenaBiomeRecruitingLyme Disease | Lyme Disease, ChronicUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Johns Hopkins UniversityEnrolling by invitation
-
Optimal Health ResearchCompletedPost-Lyme Disease Syndrome (PLDS)United States
-
Optimal Health ResearchCompletedPost-Lyme Disease Syndrome (PLDS)United States
-
Spaulding Rehabilitation HospitalSuspended
-
Sorlandet Hospital HFSouth-Eastern Norway Regional Health AuthorityCompleted
Clinical Trials on ceftriaxone
-
Baxter Healthcare CorporationHalozyme TherapeuticsCompleted
-
National Institute of Neurological Disorders and...CompletedLyme Disease | Lyme NeuroborreliosisUnited States
-
Yale UniversityStanley Medical Research InstituteTerminated
-
Association Pour La Promotion A Tours De La Reanimation...UnknownSepsis | Septic Shock | Severe SepsisFrance
-
University Medical Centre LjubljanaUnknown
-
Nantes University HospitalCompletedMeningitis | Neurological InfectionsFrance
-
Makerere UniversityCompleted
-
Fundación Pública Andaluza para la gestión de la...CompletedInfectious EndocarditisSpain
-
The Grant Medical College & Sir J.J. Group of HospitalsRecruitingSurgical Wound Infection | Surgical Site InfectionIndia
-
University of RochesterCompleted