Clinical trials: Borrelia Infections
Lyme Disease
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.
- Trial name
- IXO-01 (NCT01243008)
- Testing
- Application of SHB001
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Lyme Disease
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe.
- Trial name
- VALOR (NCT05477524)
- Testing
- VLA15, Saline
- Where
- 129 sites in United States, Canada and 5 more
- Volunteers
- 12,546 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lyme Disease, Lyme Neuroborreliosis
Brain Imaging and Retreatment Study of Persistent Lyme Disease
The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine…
- Trial name
- NCT00037479
- Testing
- ceftriaxone
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Lyme Borreliosis, Nervous System
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without…
- Trial name
- NCT03010228
- Testing
- VLA15 with Alum, VLA15 without Alum
- Where
- 5 sites in United States, Belgium
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lyme Disease, Pediatric Infectious Disease
Next Generation Sequencing Detection of Lyme Disease
Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a single blood sample, potentially improving its sensitivity compared to PCR testing, which only detects predetermined larger strands of…
- Conditions
- Lyme Disease, Pediatric Infectious Disease, Erythema Migrans, Lyme Arthritis
- Trial name
- NCT03505879
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Stony Brook University
Lyme Disease
Novel Diagnostics for Early Lyme Disease
There are more than 300,000 new cases of Lyme disease every year in the US. Lyme disease is a dangerous bacterial infection transmitted by tick bites and it becomes increasingly severe as the infection progresses.
- Trial name
- NCT03963635
- Testing
- MicroB-plex Lyme Immunoassay
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- MicroB-plex, Inc.
Lyme Borreliosis
A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults
The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.
- Trial name
- NCT07226882
- Testing
- VLA15
- Where
- 6 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lyme Disease
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms.
- Trial name
- NCT00001539
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum
Anti-phospolipid Antibodies in Lyme Borreliosis
Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B.
- Conditions
- Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum, Blood Donors
- Trial name
- NCT06929546
- Testing
- Anti-phospholipid antibodies
- Where
- Slovenia
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
Lyme Disease
Lyme Test Indication Combinations (LyTIC) Study
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
- Trial name
- LyTIC (NCT03201042)
- Testing
- PCR based assay, Serology based assay, Tcell based assay
- Where
- 60 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Oxford Immunotec
Lyme Disease
First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People
This is a research study of the investigational drug 2217LS in healthy volunteers. Investigational means 2217LS is a new drug that has not been approved for the treatment of any disease.
- Trial name
- NCT04863287
- Testing
- 2217LS, 0.9% Sodium Chloride (NaCl)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- MassBiologics
Erythema Chronicum Migrans
Duration of Antibiotic Treatment of Erythema Migrans
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
- Trial name
- NCT00910715
- Testing
- doxycycline
- Where
- Slovenia
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
Prophylaxis of Lyme Borreliosis
Phase 1/2 Lyme Vaccine Study
Section 1: The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy…
- Trial name
- NCT01504347
- Testing
- Multivalent recombinant OspA Lyme Borreliosis Vaccine
- Where
- 8 sites in Austria, Germany
- Volunteers
- 1,630 people, healthy volunteers welcome
- Sponsor
- Baxalta now part of Shire
Rheumatic Diseases, Adult Onset Still Disease
Rheumatology Patient Registry and Biorepository
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.
- Conditions
- Rheumatic Diseases, Adult Onset Still Disease, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- NCT04402086
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Yale University
Erythema Chronicum Migrans
Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans
A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question.
- Trial name
- NCT03584919
- Testing
- doxycycline, Cefuroxime Axetil 500Mg Tab, control subjects
- Volunteers
- 509 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
Lyme Disease
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
- Trial name
- NCT04835792
- Testing
- Stool and blood collection
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- FlightPath Biosciences, Inc.
Lyme Disease
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
- Trial name
- NCT07562087
- Testing
- TP-05 (lotilaner) Low Dose, TP-05 (lotilaner) High Dose
- Where
- 19 sites in United States
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
The Precision Mito- Mito Map COMPASS Study
Mito Map is a research tool that produces an Energy Score from information provided by a participant. This remote observational study has an initial enrollment target of 400 adults across seven prespecified cohorts: healthy…
- Conditions
- Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome, Post-COVID-19 Condition, Postural Orthostatic Tachycardia Syndrome
- Trial name
- COMPASS (NCT07856121)
- Testing
- Mito Map Energy Score and Home Functional Assessments
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- AI Agent Vault, Inc. d/b/a Precision Mito
Long COVID, PTLDs
A Prospective Study to Evaluate the Role of T-Cell Dysfunction in Patients Who Present Symptoms Associated With Long COVID, Lyme Disease and Myalic Encephalomyelitis / Chronic Fatigue Syndrome Using the Vira Immune Fluorospot T Cell Assay
This is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS.
- Conditions
- Long COVID, PTLDs, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)
- Trial name
- NCT06731179
- Where
- 3 sites in United Kingdom
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- ViraxBio Labs
Aseptic Meningitis
Aseptic Meningoencephalitis in Slovenia
The main objective of this study is: to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia to assess the clinical course and outcome of tick-borne encephalitis and Lyme neuroborreliosis to characterize…
- Trial name
- NCT02328469
- Testing
- symptomatic therapy, Ceftriaxone or Doxycycline, questionnaire
- Where
- 2 sites in Slovenia
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana