NCT00170638

Brief Summary

The purpose of this study is to gain a better understanding of how immunity to tuberculosis (TB) is maintained in children. When children get tuberculosis, it is more likely to spread to other parts of the body than when adults get it. This study will compare the blood cells that fight TB in children to the blood cells that fight TB in adults. Children enrolled in this study will have blood drawn on 1 or 2 occasions. Adult participants will be leukapheresed, a process in which blood passes through a machine collecting specific blood cells and returning the remaining blood to the body. An estimated 260 subjects will be enrolled in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 25, 2008

Status Verified

January 1, 2008

First QC Date

September 13, 2005

Last Update Submit

April 24, 2008

Conditions

Tuberculosis

Keywords

Tuberculosis, children, infants

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children:
  • Diagnosed with latent Mtb infection (LTBI), localized tuberculosis (TB), or disseminated TB.
  • Age less than or equal to 10 years.
  • Adults:
  • Diagnosed with localized TB or LTBI.
  • All individuals with LTBI will be healthy.
  • Individuals with localized TB will have been treated for TB for at least 1 month.

You may not qualify if:

  • Older children 11-17 years old.
  • Children who are immunocompromised.
  • Immunocompromised adults.
  • Pregnant women.
  • Non-English or non-Spanish speaking individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Study Completion

April 1, 2010

Last Updated

April 25, 2008

Record last verified: 2008-01

Locations

US(1)