Taking people in United StatesNo phase

Following and treating people with active Lyme disease over time

Follows people with active Lyme disease to learn more about the infection.

Key facts

Who runs it: National Institute of Allergy and Infectious Diseases (NIAID)
Where: Bethesda, United StatesSee the site
Trial code: NCT00028080
Registry title: Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Status: Recruiting
People taking part: 500 people, planned
Started: 16 Jan 2002
Type of study: Observational
Record updated: 12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with active Lyme disease, to examine, treat and follow them over time. Only standard, approved treatments are used.

Age: 2 Years to 99 Years. Only adults 18 years or older are asked to have leukapheresis (white blood cell collection).
Sex: All sexes can join.
Disease stage: Active Lyme disease at the first NIH visit, diagnosed by the CDC case definition.

Main reasons for not taking part

Post treatment Lyme disease syndrome (lasting symptoms after Lyme treatment).
Very poor following of study visits or instructions, in the investigator's opinion.
No private doctor for other medical problems and emergencies.
For leukapheresis only: weight 110 pounds (50 kg) or less, heart, lung, kidney or bleeding disease, positive HIV, HCV or HBsAg tests, or being pregnant or nursing.
For leukapheresis only: hemoglobin 11 g/dL or less (males) or 10 g/dL or less (females), platelets 150 k/mm(3) or less, WBC 3.5 x 10(3) uL or less, or MCV 80 or less.

The registry criteria, word for word

Show all 15 criteriaShow less

Who cannot take part

Adequate peripheral venous access; 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:
MCV above 80; Women who are able to conceive children must have a negative pregnancy test within 2 weeks before the procedure
Post treatment Lyme disease syndrome
No known heart, lung, kidney disease, or bleeding disorders
Negative HIV, HCV and HBsAg serologies
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
Age 18 years or above
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 BE ASKED TO UNDERGO APHERESIS INCLUDE:
Weight greater than 110 pounds
Female subjects should not be pregnant or nursing

Other 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 2 and 99 years old?

Where in United States

National Institutes of Health Clinical CenterBethesda, United StatesContact: Ashley M ThomasTaking people

About the trial

What the trial wants to find out

This study is designed to establish a population of patients with Lyme disease for evaluation, treatment and follow-up to learn more about the infection.

Read full original descriptionShow less

Patients with active Lyme disease may be eligible for this study.

Participants will have a medical history and physical examination and diagnostic evaluations as appropriate to their individual condition. Laboratory tests may include routing blood and urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and tests for allergic or immune responses. Treatment will include only medications approved by the Food and Drug Administration, given according to accepted dose schedules and ways of taking the medicines. All diagnostic tests and treatments will be according to standard medical practice for the disease. No experimental procedures will be offered under this protocol.

Patients will be followed as needed for evaluation and treatment of their condition. In general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later, and then every 6 to 12 months. More frequent visits may be required or less frequent visits may be allowed, depending on the individual s condition.

Participants may be asked to undergo the following additional procedures for research purposes:

* Extra blood draws to study Lyme disease and other inflammatory conditions. Blood will be drawn from arm veins. The total amount drawn during any 6-week period will not exceed 450 cc (30 tablespoons) for adults and 7 cc (1/2 tablespoon) per kilogram (2.2 pounds) of body weight for children under 18 years of age. * Leukapheresis to collect large numbers of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body through the same needle. Only adults 18 years of age and older will be asked to undergo leukapheresis.