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NIH launches major lyme disease observation study to uncover hidden clues

NCT ID NCT00028080

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 10 times

Summary

This study follows 500 people with active Lyme disease to learn more about the infection. Participants receive standard FDA-approved treatments and undergo tests like blood draws and leukapheresis. The goal is to explore biological markers, track clinical outcomes, and understand immune responses—not to test new drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could improve understanding of Lyme disease, helping to identify biological markers and better track patient outcomes.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test new therapies or cures, and results may take years to translate into clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2002

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

primary clinical

Ages

2 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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 BE ASKED TO UNDERGO APHERESIS INCLUDE: * 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 * 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: * 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.

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Conditions

The condition(s) this trial relates to.

Infections Lyme disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lyme disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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