View clinical trials related to Lyme Disease.
Filter by:This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease. This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.
Background: The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases of Lyme disease are cured by antibiotics, but some patients continue to experience symptoms despite the absence of detectable Lyme bacteria. Xenodiagnosis uses a vector to detect the presence of a disease-causing microbe. Researchers will use live, laboratory-bred ticks to see if Lyme disease bacteria can be detected in people after completing antibiotic therapy and if that is more common in people who continue to experience symptoms such as fatigue and joint pain. Objectives: - To see if ticks can be used to detect B. burgdorferi in people who have had Lyme disease and received antibiotic therapy and if it correlates with persistent symptoms. Eligibility: - Adults at least 18 years old who have: - Untreated erythema migrans (the Lyme disease rash); OR - Untreated Lyme arthritis; OR - Continuing symptoms after treatment for Lyme disease; OR - Had Lyme disease and antibiotic treatment within the past 12 months. - Healthy volunteers Design: - Participants will be screened with medical history, physical exam, and blood tests. - Visit 1: - Blood and urine tests, health questionnaire. - Up to 30 laboratory-bred, pathogen-free, larval ticks (each smaller than a poppy seed) will be placed under a dressing. - Participants may have two small biopsies of skin . - 4 6 days later, Visit 2: - Dressing will be removed and ticks will be collected. - Participants will answer symptom questions. - If many ticks are still attached, participants will have to come back the next day. If not enough ticks feed successfully, the procedure may be repeated. - Participants will keep a diary of symptoms for 30 days. Over 3 months, they will be return to the clinic 3 times to see how they feel and answer questionnaires. Test results will be discussed.
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans). This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).
The investigators wish to conduct a preliminary study to examine the efficacy of meditation among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators will use the breathing, meditation, and stretching techniques common to Kundalini Yoga practice. The investigators plan to assess the degree in which this practice can reduce Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients with PTLDS, the primary focus of this study will be fatigue and pain. Secondary outcomes will include cognitive complaints, physical and mental functioning, medical utilization, somatic symptoms, and psychopathology.
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll.
Background: - While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main etiologic agents are B. afzelii and B. garinii. - Controversy exists over the significance and even the existence of post-Lyme disease symptoms because of the high rate of similar background symptoms in the general population. Purpose: The two main purposes of this European, prospective clinical trial in which doxycycline and cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and which included a control group to address the significance of post-Lyme disease symptoms are: - To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the treatment of erythema migrans using clinical and bacteriological criteria (noninferiority testing approach), and - to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM with antibiotics and the frequency of similar symptoms in control subjects without Lyme disease.
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 adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study. Section 2: An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.
Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection. Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement about what antibiotic treatment that should be given. An RCT with the three most common antibiotics used, will support data for revision of national guidelines.
IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.
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.