Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028080
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2001-12-11
Brief Title:
Evaluation Treatment and Follow-up of Patients With Lyme Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation Treatment and Follow-up of Patients With Lyme Disease
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 12 tablespoon per kilogram 22 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
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 12 tablespoon per kilogram 22 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
Detailed Description:
Lyme disease is a multisystem illness caused by the spirochete Borrelia burgdorferi and it is the most common vector-borne illness in the United States This protocol is designed to offer evaluation therapy and follow up to patients with Lyme disease This is a natural history study which has the objective of developing a rigorously defined population of patients with Lyme disease to serve as the basis of research in multiple aspects of the infection These research sub-projects have emphasis in exploring the biological markers of Borrelia infections assessment of clinical course and outcomes of patients with Lyme infection and the immunological response to B burgdorferi infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-I-0055 | None | None | None |