NCT00001477

Brief Summary

Patients are exposed to infectious agents regularly, regardless of their immunologic status. Traditionally clinicians have decided to institute prophylaxis based on epidemiologic factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method that is non-invasive, such as quantitative PCR, would be desirable to more precisely define those who would benefit from prophylaxis. Similarly, when patients develop disease and are being treated, quantitative, non-invasive techniques are needed to assess response to therapy. This project is designed to develop and test quantitative tests using blood, urine, or sputum samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1995

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Communicable InfectionMonitoringNon-Invasive TestsOpportunistic Infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients older than 18 years of age. Ability to give informed consent. No medical contraindication to phlebotomy. Epidemiologically at risk for tuberculosis or for an opportunistic infection. Patients who can identify a responsible health care provider as someone willing to provide clinical information and to receive medically important information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Drouet E, Colimon R, Michelson S, Fourcade N, Niveleau A, Ducerf C, Boibieux A, Chevallier M, Denoyel G. Monitoring levels of human cytomegalovirus DNA in blood after liver transplantation. J Clin Microbiol. 1995 Feb;33(2):389-94. doi: 10.1128/jcm.33.2.389-394.1995.

    PMID: 7714198BACKGROUND
  • Patel R, Smith TF, Espy M, Wiesner RH, Krom RA, Portela D, Paya CV. Detection of cytomegalovirus DNA in sera of liver transplant recipients. J Clin Microbiol. 1994 Jun;32(6):1431-4. doi: 10.1128/jcm.32.6.1431-1434.1994.

    PMID: 8077384BACKGROUND
  • Spector SA, Merrill R, Wolf D, Dankner WM. Detection of human cytomegalovirus in plasma of AIDS patients during acute visceral disease by DNA amplification. J Clin Microbiol. 1992 Sep;30(9):2359-65. doi: 10.1128/jcm.30.9.2359-2365.1992.

    PMID: 1328287BACKGROUND

MeSH Terms

Conditions

Communicable DiseasesOpportunistic Infections

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

August 1, 1995

Study Completion

October 1, 2000

Last Updated

March 4, 2008

Record last verified: 2000-02

Locations