Xenodiagnosis After Antibiotic Treatment for Lyme Disease
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
burgdorferi in people who have had Lyme disease
and received antibiotic therapy and if it correlates with persistent symptoms.
not enough ticks feed successfully, the procedure may be repeated.
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
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|Eligible Ages||18 Years and Over|
- - INCLUSION CRITERIA Criteria for the diagnosis and therapy for Lyme disease can be found at The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America .
- - within one dose - on antibiotic therapy).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|National Institute of Allergy and Infectious Diseases (NIAID)|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Adriana R Marques, M.D.|
|Principal Investigator Affiliation||National Institute of Allergy and Infectious Diseases (NIAID)|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Lyme disease is the most common vector borne disease in the United States. Although antibiotic therapy is clinically effective in treating the symptoms of Lyme disease for most patients early in the course of disease, a significant number of patients who receive therapy report persistent symptoms. The cause of persistent symptoms after antibiotic therapy for Lyme disease is an area of great controversy. Recent studies have shown that the organism (Borrelia burgdorferi) may persist in animals after antibiotic therapy and can be detected by using the natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). Whether this occurs in humans is unknown. Currently available tests for human Lyme disease do not allow determination of persistent infection after antibiotic therapy. We performed the first study of the use of
- I. scapularis larva for the xenodiagnosis of B.
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