Lyme Disease

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Clinical Trials for Lyme Disease

General Purpose: Research related to Lyme disease frequently seeks to develop new and improved methods for treating and preventing the disease, develop more reliable methods for diagnosing Lyme disease.

Also to ealuate the biological and genetic aspects of Lyme disease in an effort to better understand how it affects the body. Other studies evaluate the effectiveness of different types of antibiotic therapies commonly used to treat Lyme disease, as well as the effectiveness of potential vaccines developed to prevent it.

Lyme Disease Clinical Trials Continued (Click to Open)

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Clinical Trials for Lyme Disease

What do clinical trials for Lyme disease involve?

Clinical trials will vary widely in the information they collect, as well as the tests and procedures they use. All of these factors will depend on individual study designs, which will differ greatly between trials. However, below is a list of common procedures and data that are frequently collected during a trial for Lyme disease:

  • Blood tests to measure antibodies to the bacteria that causes Lyme disease (most commonly used test is known as the ELISA for Lyme disease).
  • Electrocardiogram (EKG)
  • Echocardiogram (to look at the heart)
  • Spinal tap to examine spinal fluid
  • MRI of the brain

Examples of Lyme disease-related research topics:

  • Education related to techniques for minimizing the risk of exposure to infected ticks.
  • Studies comparing two separate testing methods for Lyme disease to determine which is more accurate.
  • Studies to determine the quickest way to diagnose Lyme disease and thereby minimize treatment delays.
  • Studies to evaluate the use of extended antibiotic therapy for individuals who do not receive complete relief of their symptoms following a standard course of antibiotic therapy.

 

Suggested search terms for Lyme Disease Clinical Trials: 

“Borreliosis”, “Lyme disease treatment,” “Lyme disease prevention,” “Lyme disease diagnosis,” “chronic Lyme disease,” “Lyme disease symptoms,” and “chronic Lyme disease treatment.”



Sofia 2 Lyme FIA Whole Blood Clinical Study


Condition:   Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)
Intervention:   Device: Sofia 2 Lyme FIA testing
Sponsor:   Quidel Corporation
Recruiting


Lyme Test Indication Combinations (LyTIC) Study


Condition:   Lyme Disease
Interventions:   Diagnostic Test: PCR based assay;   Diagnostic Test: Serology based assay;   Diagnostic Test: Tcell based assay
Sponsor:   Oxford Immunotec
Recruiting


Duration of Doxycycline Treatment in EM Patients


Condition:   Erythema Chronicum Migrans
Interventions:   Drug: Doxycycline 100 MG Oral Tablet bid, 7 days;   Drug: Doxycycline 100 MG Oral Tablet bid, 14 days;   Drug: Controls without a history of lyme disease.
Sponsors:   University Medical Centre Ljubljana;   University of Ljubljana School of Medicine, Slovenia
Not yet recruiting


CD8 Reactivity to Microorganisms in Blood and Breast Milk


Conditions:   Tuberculosis;   Leprosy;   Pertussis;   Lyme Disease
Intervention:  
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting


Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis


Condition:   Lyme Borreliosis, Nervous System
Interventions:   Biological: VLA15 with Alum;   Biological: VLA15 without Alum
Sponsor:   Valneva Austria GmbH
Active, not recruiting


A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease


Condition:   Lyme Disease
Intervention:   Device: Borrelia Diagnostic Test
Sponsor:   Advanced Laboratory Services, Inc.
Recruiting


Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis


Condition:   Neuroborreliosis, Borrelia Burgdorferi
Interventions:   Drug: Doxycycline;   Drug: Placebo
Sponsor:   Sorlandet Hospital HF
Enrolling by invitation


Lyme Borreliosis and Early Cutaneous Diagnostic


Condition:   Erythema Migrans
Intervention:   Procedure: Skin biopsies
Sponsor:   University Hospital, Strasbourg, France
Recruiting


Xenodiagnosis After Antibiotic Treatment for Lyme Disease


Condition:   Lyme Disease
Interventions:   Procedure: Skin biopsy;   Procedure: Blood draw;   Other: Xenodiagnosis
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting


Cytokines and Chemokines in Erythema Migrans


Condition:   Erythema Migrans
Intervention:   Drug: antibiotic treatment
Sponsors:   University Medical Centre Ljubljana;   University of Ljubljana School of Medicine, Slovenia;   Medical University of Vienna;   Harvard University
Recruiting


Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford


Conditions:   Rare Disorders;   Undiagnosed Disorders;   Disorders of Unknown Prevalence;   Cornelia De Lange Syndrome;   Prenatal Benign Hypophosphatasia;   Perinatal Lethal Hypophosphatasia;   Odontohypophosphatasia;   Adult Hypophosphatasia;   Childhood-onset Hypophosphatasia;   Infantile Hypophosphatasia;   Hypophosphatasia;   Kabuki Syndrome;   Bohring-Opitz Syndrome;   Narcolepsy Without Cataplexy;   Narcolepsy-cataplexy;   Hypersomnolence Disorder;   Idiopathic Hypersomnia Without Long Sleep Time;   Idiopathic Hypersomnia With Long Sleep Time;   Idiopathic Hypersomnia;   Kleine-Levin Syndrome;   Kawasaki Disease;   Leiomyosarcoma;   Leiomyosarcoma of the Corpus Uteri;   Leiomyosarcoma of the Cervix Uteri;   Leiomyosarcoma of Small Intestine;   Acquired Myasthenia Gravis;   Addison Disease;   Hyperacusis (Hyperacousis);   Juvenile Myasthenia Gravis;   Transient Neonatal Myasthenia Gravis;   Williams Syndrome;   Lyme Disease;   Myasthenia Gravis;   Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome);   Isolated Klippel-Feil Syndrome;   Frasier Syndrome;   Denys-Drash Syndrome;   Beckwith-Wiedemann Syndrome;   Emanuel Syndrome;   Isolated Aniridia;   Beckwith-Wiedemann Syndrome Due to Paternal Uniparental Disomy of Chromosome 11;   Beckwith-Wiedemann Syndrome Due to Imprinting Defect of 11p15;   Beckwith-Wiedemann Syndrome Due to 11p15 Translocation/Inversion;   Beckwith-Wiedemann Syndrome Due to 11p15 Microduplication;   Beckwith-Wiedemann Syndrome Due to 11p15 Microdeletion;   Axenfeld-Rieger Syndrome;   Aniridia-intellectual Disability Syndrome;   Aniridia - Renal Agenesis - Psychomotor Retardation;   Aniridia - Ptosis - Intellectual Disability - Familial Obesity;   Aniridia - Cerebellar Ataxia - Intellectual Disability;   Aniridia - Absent Patella;   Aniridia;   Peters Anomaly - Cataract;   Peters Anomaly;   Potocki-Shaffer Syndrome;   Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11;   Silver-Russell Syndrome Due to Imprinting Defect of 11p15;   Silver-Russell Syndrome Due to 11p15 Microduplication;   Syndromic Aniridia;   WAGR Syndrome;   Wolf-Hirschhorn Syndrome;   4p16.3 Microduplication Syndrome;   4p Deletion Syndrome, Non-Wolf-Hirschhorn Syndrome;   Autosomal Recessive Stickler Syndrome;   Stickler Syndrome Type 2;   Stickler Syndrome Type 1;   Stickler Syndrome;   Mucolipidosis Type 4;   X-linked Spinocerebellar Ataxia Type 4;   X-linked Spinocerebellar Ataxia Type 3;   X-linked Intellectual Disability - Ataxia - Apraxia;   X-linked Progressive Cerebellar Ataxia;   X-linked Non Progressive Cerebellar Ataxia;   X-linked Cerebellar Ataxia;   Vitamin B12 Deficiency Ataxia;   Toxic Exposure Ataxia;   Unclassified Autosomal Dominant Spinocerebellar Ataxia;   Thyroid Antibody Ataxia;   Sporadic Adult-onset Ataxia of Unknown Etiology;   Spinocerebellar Ataxia With Oculomotor Anomaly;   Spinocerebellar Ataxia With Epilepsy;   Spinocerebellar Ataxia With Axonal Neuropathy Type 2;   Spinocerebellar Ataxia Type 8;   Spinocerebellar Ataxia Type 7;   Spinocerebellar Ataxia Type 6;   Spinocerebellar Ataxia Type 5;   Spinocerebellar Ataxia Type 4;   Spinocerebellar Ataxia Type 37;   Spinocerebellar Ataxia Type 36;   Spinocerebellar Ataxia Type 35;   Spinocerebellar Ataxia Type 34;   Spinocerebellar Ataxia Type 32;   Spinocerebellar Ataxia Type 31;   Spinocerebellar Ataxia Type 30;   Spinocerebellar Ataxia Type 3;   Spinocerebellar Ataxia Type 29;   Spinocerebellar Ataxia Type 28;   Spinocerebellar Ataxia Type 27;   Spinocerebellar Ataxia Type 26;   Spinocerebellar Ataxia Type 25;   Spinocerebellar Ataxia Type 23;   Spinocerebellar Ataxia Type 22;   Spinocerebellar Ataxia Type 21;   Spinocerebellar Ataxia Type 20;   Spinocerebellar Ataxia Type 2;   Spinocerebellar Ataxia Type 19/22;   Spinocerebellar Ataxia Type 18;   Spinocerebellar Ataxia Type 17;   Spinocerebellar Ataxia Type 16;   Spinocerebellar Ataxia Type 15/16;   Spinocerebellar Ataxia Type 14;   Spinocerebellar Ataxia Type 13;   Spinocerebellar Ataxia Type 12;   Spinocerebellar Ataxia Type 11;   Spinocerebellar Ataxia Type 10;   Spinocerebellar Ataxia Type 1 With Axonal Neuropathy;   Spinocerebellar Ataxia Type 1;   Spinocerebellar Ataxia - Unknown;   Spinocerebellar Ataxia - Dysmorphism;   Non Progressive Epilepsy and/or Ataxia With Myoclonus as a Major Feature;   Spectrin-associated Autosomal Recessive Cerebellar Ataxia;   Spasticity-ataxia-gait Anomalies Syndrome;   Spastic Ataxia With Congenital Miosis;   Spastic Ataxia - Corneal Dystrophy;   Spastic Ataxia;   Rare Hereditary Ataxia;   Rare Ataxia;   Recessive Mitochondrial Ataxia Syndrome;   Progressive Epilepsy and/or Ataxia With Myoclonus as a Major Feature;   Posterior Column Ataxia - Retinitis Pigmentosa;   Post-Stroke Ataxia;   Post-Head Injury Ataxia;   Post Vaccination Ataxia;   Polyneuropathy - Hearing Loss - Ataxia - Retinitis Pigmentosa - Cataract;   Muscular Atrophy - Ataxia - Retinitis Pigmentosa - Diabetes Mellitus;   Non-progressive Cerebellar Ataxia With Intellectual Disability;   Non-hereditary Degenerative Ataxia;   Paroxysmal Dystonic Choreathetosis With Episodic Ataxia and Spasticity;   Olivopontocerebellar Atrophy - Deafness;   NARP Syndrome;   Myoclonus - Cerebellar Ataxia - Deafness;   Multiple System Atrophy, Parkinsonian Type;   Multiple System Atrophy, Cerebellar Type;   Multiple System Atrophy;   Maternally-inherited Leigh Syndrome;   Machado-Joseph Disease Type 3;   Machado-Joseph Disease Type 2;   Machado-Joseph Disease Type 1;   Lethal Ataxia With Deafness and Optic Atrophy;   Leigh Syndrome;   Leukoencephalopathy With Mild Cerebellar Ataxia and White Matter Edema;   Leukoencephalopathy - Ataxia - Hypodontia - Hypomyelination;   Leigh Syndrome With Nephrotic Syndrome;   Leigh Syndrome With Leukodystrophy;   Leigh Syndrome With Cardiomyopathy;   Late-onset Ataxia With Dementia;   Intellectual Disability-hyperkinetic Movement-truncal Ataxia Syndrome;   Infection or Post Infection Ataxia;   Infantile-onset Autosomal Recessive Nonprogressive Cerebellar Ataxia;   Infantile Onset Spinocerebellar Ataxia;   GAD Ataxia;   Hereditary Episodic Ataxia;   Gliadin/Gluten Ataxia;   Friedreich Ataxia;   Fragile X-associated Tremor/Ataxia Syndrome;   Familial Paroxysmal Ataxia;   Exposure to Medications Ataxia;   Episodic Ataxia With Slurred Speech;   Episodic Ataxia Unknown Type;   Episodic Ataxia Type 7;   Episodic Ataxia Type 6;   Episodic Ataxia Type 5;   Episodic Ataxia Type 4;   Episodic Ataxia Type 3;   Episodic Ataxia Type 1;   Epilepsy and/or Ataxia With Myoclonus as Major Feature;   Early-onset Spastic Ataxia-neuropathy Syndrome;   Early-onset Progressive Neurodegeneration - Blindness - Ataxia - Spasticity;   Early-onset Cerebellar Ataxia With Retained Tendon Reflexes;   Early-onset Ataxia With Dementia;   Childhood-onset Autosomal Recessive Slowly Progressive Spinocerebellar Ataxia;   Dilated Cardiomyopathy With Ataxia;   Cataract - Ataxia - Deafness;   Cerebellar Ataxia, Cayman Type;   Cerebellar Ataxia With Peripheral Neuropathy;   Cerebellar Ataxia - Hypogonadism;   Cerebellar Ataxia - Ectodermal Dysplasia;   Cerebellar Ataxia - Areflexia - Pes Cavus - Optic Atrophy - Sensorineural Hearing Loss;   Brain Tumor Ataxia;   Brachydactyly - Nystagmus - Cerebellar Ataxia;   Benign Paroxysmal Tonic Upgaze of Childhood With Ataxia;   Autosomal Recessive Syndromic Cerebellar Ataxia;   Autosomal Recessive Spastic Ataxia With Leukoencephalopathy;   Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay;   Autosomal Recessive Spastic Ataxia - Optic Atrophy - Dysarthria;   Autosomal Recessive Spastic Ataxia;   Autosomal Recessive Metabolic Cerebellar Ataxia;   Autosomal Dominant Spinocerebellar Ataxia Due to Repeat Expansions That do Not Encode Polyglutamine;   Autosomal Recessive Ataxia, Beauce Type;   Autosomal Recessive Ataxia Due to Ubiquinone Deficiency;   Autosomal Recessive Ataxia Due to PEX10 Deficiency;   Autosomal Recessive Degenerative and Progressive Cerebellar Ataxia;   Autosomal Recessive Congenital Cerebellar Ataxia Due to MGLUR1 Deficiency;   Autosomal Recessive Congenital Cerebellar Ataxia Due to GRID2 Deficiency;   Autosomal Recessive Congenital Cerebellar Ataxia;   Autosomal Recessive Cerebellar Ataxia-pyramidal Signs-nystagmus-oculomotor Apraxia Syndrome;   Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to WWOX Deficiency;   Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to TUD Deficiency;   Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to KIAA0226 Deficiency;   Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome;   Autosomal Recessive Cerebellar Ataxia With Late-onset Spasticity;   Autosomal Recessive Cerebellar Ataxia Due to STUB1 Deficiency;   Autosomal Recessive Cerebellar Ataxia Due to a DNA Repair Defect;   Autosomal Recessive Cerebellar Ataxia - Saccadic Intrusion;   Autosomal Recessive Cerebellar Ataxia - Psychomotor Retardation;   Autosomal Recessive Cerebellar Ataxia - Blindness - Deafness;   Autosomal Recessive Cerebellar Ataxia;   Autosomal Dominant Spinocerebellar Ataxia Due to a Polyglutamine Anomaly;   Autosomal Dominant Spinocerebellar Ataxia Due to a Point Mutation;   Autosomal Dominant Spinocerebellar Ataxia Due to a Channelopathy;   Autosomal Dominant Spastic Ataxia Type 1;   Autosomal Dominant Spastic Ataxia;   Autosomal Dominant Optic Atrophy;   Ataxia-telangiectasia Variant;   Ataxia-telangiectasia;   Autosomal Dominant Cerebellar Ataxia, Deafness and Narcolepsy;   Autosomal Dominant Cerebellar Ataxia Type 4;   Autosomal Dominant Cerebellar Ataxia Type 3;   Autosomal Dominant Cerebellar Ataxia Type 2;   Autosomal Dominant Cerebellar Ataxia Type 1;   Autosomal Dominant Cerebellar Ataxia;   Ataxia-telangiectasia-like Disorder;   Ataxia-intellectual Disability-oculomotor Apraxia-cerebellar Cysts Syndrome;   Ataxia-deafness-intellectual Disability Syndrome;   Ataxia With Vitamin E Deficiency;   Ataxia With Dementia;   Ataxia Neuropathy Spectrum;   Ataxia - Tapetoretinal Degeneration;   Ataxia - Photosensitivity - Short Stature;   Ataxia - Pancytopenia;   Ataxia - Oculomotor Apraxia Type 1;   Ataxia - Hypogonadism - Choroidal Dystrophy;   Ataxia - Other;   Ataxia - Genetic Diagnosis - Unknown;   Acquired Ataxia;   Adult-onset Autosomal Recessive Cerebellar Ataxia;   Alcohol Related Ataxia;   Multiple Endocrine Neoplasia;   Multiple Endocrine Neoplasia Type II;   Multiple Endocrine Neoplasia Type 1;   Multiple Endocrine Neoplasia Type 2;   Multiple Endocrine Neoplasia, Type IV;   Multiple Endocrine Neoplasia, Type 3;   Multiple Endocrine Neoplasia (MEN) Syndrome;   Multiple Endocrine Neoplasia Type 2B;   Multiple Endocrine Neoplasia Type 2A;   Atypical Hemolytic Uremic Syndrome;   Atypical HUS;   Wiedemann-Steiner Syndrome;   Breast Implant-Associated Anaplastic Large Cell Lymphoma;   Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA);   Hemophagocytic Lymphohistiocytosis;   Behcet's Disease
Intervention:  
Sponsors:   Sanford Health;   National Ataxia Foundation;   International WAGR Syndrome Association;   4p- Support Group;   ML4 Foundation;   Cornelia de Lange Syndrome Foundation;   Stickler Involved People;   Kawasaki Disease Foundation;   Klippel-Feil Syndrome Alliance;   Klippel-Feil Syndrome Freedom;   Hyperacusis Research Limited;   Hypersomnia Foundation;   Kabuki Syndrome Network;   Kleine-Levin Syndrome Foundation;   Leiomyosarcoma Direct Research Foundation;   Marinesco-Sjogren Syndrome Support Group;   Mucolipidosis Type IV (ML4) Foundation;   People with Narcolepsy 4 People with Narcolepsy (PWN4PWN);   Soft Bones Incorporated;   American Multiple Endocrine Neoplasia Support;   Atypical Hemolytic Uremic Syndrome Foundation;   All Things Kabuki;   Wiedemann-Steiner Syndrome Foundation;   Breast Implant Victim Advocates;   PROS Foundation;   American Behcet's Disease Association
Recruiting


Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)


Conditions:   Visceral Leishmaniasis;   Human African Trypanosomiasis;   Enteric Fever;   Melioidosis;   Brucellosis;   Leptospirosis;   Relapsing Fever;   Rickettsial Diseases;   HIV;   Tuberculosis;   Malaria;   Amoebic Liver Abscess
Interventions:   Device: rk28 ICT;   Device: IT LEISH (rK39);   Device: Immunochromatographic HAT test;   Device: HAT Serostrip;   Device: Card Agglutination Trypanosoma Test (CATT)-10;   Device: Typhidot M;   Device: S. typhi IgM/IgG;   Device: Test-it Typhoid IgM;   Device: Test-it Leptospirosis IgM;   Device: Leptospira IgG/IgM
Sponsors:   University Hospital, Geneva;   Institute of Tropical Medicine, Belgium;   B.P. Koirala Institute of Health Sciences;   Institut National de Recherche Biomédicale, Kinshasa, DRC;   University of Khartoum;   Sihanouk Hospital Center of HOPE
Completed


Antibiotic Treatment of Multiple Erythema Migrans


Condition:   Multiple Erythema Migrans
Interventions:   Drug: ceftriaxone;   Drug: doxycycline;   Other: erythema migrans patients treated with doxycycline
Sponsor:   University Medical Centre Ljubljana
Recruiting


Searching for Persistence of Infection in Lyme Disease


Conditions:   Lyme Disease;   Borrelia Burgdorferi
Interventions:   Procedure: Skin Biopsy;   Device: Xenodiagnosis;   Procedure: Blood Drawing
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Completed


Study on Early Lyme Neuroborreliosis


Condition:   Nervous System Lyme Borreliosis
Intervention:   Drug: ceftriaxone
Sponsor:   University Medical Centre Ljubljana
Recruiting


Duration of Antibiotic Treatment of Erythema Migrans


Condition:   Erythema Chronicum Migrans
Interventions:   Drug: doxycycline;   Drug: placebo
Sponsor:   University Medical Centre Ljubljana
Completed


Borrelia Species in Cutaneous Lyme Borreliosis


Condition:   Lyme Borreliosis
Intervention:   Other: Cutaneous biopsy
Sponsors:   University Hospital, Strasbourg, France;   Société de Dermatologie Française
Recruiting


A School-Based Intervention to Reduce Lyme Disease


Condition:   Lyme Disease
Interventions:   Behavioral: Education;   Behavioral: Control (pre and post surveys)
Sponsors:   Brigham and Women's Hospital;   Centers for Disease Control and Prevention
Unknown status


Analysis of Lyme Disease Lesions


Conditions:   Erythema Migrans Lesions;   Erythema Migrans
Intervention:  
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting


Evaluation, Treatment, and Follow-up of Patients With Lyme Disease


Condition:   Lyme Disease
Intervention:  
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting


Evaluation of Lyme Disease: Clinical, Microbiological and Immunological Characteristics


Condition:   Lyme Disease
Intervention:  
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting

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