Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy

NCT ID: NCT00001477

Last Updated: 2008-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-08-31

Study Completion Date

2000-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Communicable Diseases Opportunistic Infections

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Locations

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National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7714198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8077384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1328287 (View on PubMed)

Other Identifiers

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95-I-0176

Identifier Type: -

Identifier Source: secondary_id

950176

Identifier Type: -

Identifier Source: org_study_id

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