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Persistent Lyme Empiric Antibiotic Study Europe | Clinical Trials | Clareo Health

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Persistent Lyme Empiric Antibiotic Study Europe

Persistent Lyme Empiric Antibiotic Study Europe. A Prospective, Randomised Study Comparing Two Prolonged Oral Antibiotic Strategies After Initial Intravenous Ceftriaxone Therapy for Patients With Symptoms of Proven or Possible Persistent Lyme Disease

NCT01207739•Radboud University Medical Center

View on ClinicalTrials.gov

Summary

The purpose of the study is to establish whether prolonged antibiotic treatment of patients diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO guidelines.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or non-pregnant, non-lactating females who are 18 years or older.
•Women of child-bearing potential must agree to use contraception methods other than oral contraceptives during the study therapy period, since failure of oral contraceptives due to long-term antibiotic use has been described and doxycycline might be teratogenic.
•Patients with presumed or proven PLD. In this study, clinical suspicion of PLD is defined as complaints of musculoskeletal pain, arthritis or arthralgia, neuralgia or sensory disturbances (such as paresthesias or dysesthesias), neuropsychological or cognitive disorders, and persistent fatigue, that are:
•* temporally related to an episode of erythema migrans or otherwise proven symptomatic Lyme disease (defined as within 4 months after erythema migrans as assessed by a physician, or positive biopsy, PCR, culture, intrathecal B. burgdorferi antibodies), OR
•* accompanied by a positive B. burgdorferi IgG or IgM immunoblot (as defined by strict criteria in line with the European Union Concerted Action on Lyme Borreliosis (EUCALB)), regardless of prior ELISA IgG/IgM screening results.
•Subjects must sign a written informed consent form.

Exclusion Criteria

•Subjects with a known history of allergy or intolerance to tetracyclines, macrolides, hydroxychloroquine or ceftriaxone.
•Subjects who have had more than 5 days of antimicrobial therapy with activity against B. burgdorferi within the previous 4 weeks.
•Subjects with a presumed diagnosis of neuroborreliosis (CSF pleocytosis or intrathecal antibody production) for which intravenous antimicrobial therapy is required.
•Subjects with a known diagnosis of HIV-seropositivity or other immune disorders. (No HIV serologic testing is required for the study).
•Subjects with positive syphilis serology or signs of other spirochetal diseases.
•Subjects with moderate or severe liver disease defined as alkaline phosphatase, ALAT, or ASAT greater than 3 times upper limit of normal.
•Subjects who are receiving and cannot discontinue cisapride, astemizole, terfenadine, barbiturates, phenytoin, or carbamazepine (The concentrations of these drugs may increase during clarithromycin therapy and/or lead to reduced availability of doxycycline).
•Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents.
•Subjects who have been previously randomized into this study.
•Severe physical or psychiatric co-morbidity that interferes with participation in the study protocol, including previous medical diagnosis of rheumatic conditions, chronic fatigue syndrome or chronic pain conditions as well as insufficient command of the Dutch language.
+1 more criteria

Locations (2)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Sint Maartenskliniek

Nijmegen, Netherlands

Key Dates

Start Date

September 1, 2010

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2014

Last Updated

September 8, 2016

Enrollment

280

ACTUAL participants

Conditions

Lyme DiseaseBorrelia Infection

Interventions

Doxycycline

DRUG

Clarithromycin and hydroxychloroquine

DRUG

Placebo

DRUG

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

NCT00001539

Lyme Disease

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RECRUITING

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Persistent Lyme Empiric Antibiotic Study Europe

Inclusion Criteria

Exclusion Criteria

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

Rheumatology Patient Registry and Biorepository

Ceftriaxone for Post-Treatment Lyme Disease

Human Immune Response to Ixodes Scapularis Tick Bites

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Borrelia B-cell Diagnostics