A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease

This study has been completed.

First Received on November 2, 1999. Last Updated on August 26, 2010 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001101

Purpose

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) active infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of co-infection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, for seropositive patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).

Condition	Intervention	Phase
Lyme Disease	Drug: ceftriaxone Drug: doxycycline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease

Resource links provided by NLM:

MedlinePlus related topics: Lyme Disease

Drug Information available for: Doxycycline Doxycycline hyclate Ceftriaxone Ceftriaxone Sodium Doxycycline calcium

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	194
Study Completion Date:	March 2001
Primary Completion Date:	March 2001 (Final data collection date for primary outcome measure)

Detailed Description:

One hundred ninety-four (194) 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You may be eligible for this study if you:

Are 18 years of age or older.
Are seropositive 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 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 disease or an 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001101

Locations

United States, Massachusetts
Mark Klempner
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Publications:

Klempner MS, Hu LT, Evans J, Schmid CH, Johnson GM, Trevino RP, Norton D, Levy L, Wall D, McCall J, Kosinski M, Weinstein A. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001 Jul 12;345(2):85-92.

Klempner MS, Schmid CH, Hu L, Steere AC, Johnson G, McCloud B, Noring R, Weinstein A. Intralaboratory reliability of serologic and urine testing for Lyme disease. Am J Med. 2001 Feb 15;110(3):217-9. No abstract available.

Perides G, Charness ME, Tanner LM, Peter O, Satz N, Steere AC, Klempner MS. Matrix metalloproteinases in the cerebrospinal fluid of patients with Lyme neuroborreliosis. J Infect Dis. 1998 Feb;177(2):401-8.

Klempner M, Hu L, Johnson G. Severe physical disability and other characteristics in patients with post treatment chronic Lyme disease. VIII International Conference on Lyme Borreliosis and other Emerging Tick-Borne Diseases, Munich, Germany June 20-24, 1999.

ClinicalTrials.gov Identifier:	NCT00001101 History of Changes
Other Study ID Numbers:	DMID 97-002
Study First Received:	November 2, 1999
Last Updated:	August 26, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Ceftriaxone
Doxycycline

Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 12, 2012