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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 11, 2001

Keywords

ClinConnect Summary

This clinical trial is focused on understanding Lyme disease, a tick-borne infection. The study aims to evaluate and treat patients with active Lyme disease, helping researchers learn more about how the infection affects individuals and how best to manage it. If you have been diagnosed with active Lyme disease, you might be eligible to participate in this study.

Participants will undergo a thorough medical evaluation, which includes a physical exam, medical history review, and various tests like blood work and imaging studies, to assess their condition. If you join the study, you will receive FDA-approved treatments according to standard medical practices. You will also have follow-up visits at regular intervals to monitor your health progress. Some participants may be asked to provide extra blood samples or undergo a procedure called leukapheresis, which safely collects white blood cells for research. This trial is open to people of all ages with active Lyme disease, but those who have other specific conditions or who don't meet certain health criteria may not qualify.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation based on the CDC case definition. Study physician will review history to confirm probable cases.
• • Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.
• EXCLUSION CRITERIA:
• • Post treatment Lyme disease syndrome.
• • Unacceptably poor compliance, which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient.
• ELIGIBILITY CRITERIA TO UNDERGO APHERESIS:
• • Age 18 years or above.
• • Weight greater than 110 pounds.
• • No known heart, lung, kidney disease, or bleeding disorders.
• • Negative HIV, HCV and HBsAg serologies.
• • Female subjects should not be pregnant or nursing.
• * Patients will have a CBC performed up to 2 weeks before the procedure. In order to be able to undergo the procedure, patient must fulfill all of the below:
• • Hemoglobin greater than 11 g/dL for males and greater than 10 g/dL for females.
• • Platelets greater than 150 k/mm(3).
• • WBC greater than 3.5 x 10(3) uL.
• • MCV above 80.
• • Women who are able to conceive children must have a negative pregnancy test within 2 weeks before the procedure.