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

Primary Purpose

Communicable Diseases, Opportunistic Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Communicable Diseases focused on measuring Communicable Infection, Monitoring, Non-Invasive Tests, Opportunistic Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Allergy and Infectious Diseases (NIAID)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001477
Brief Title
Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy
Official Title
Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy
Study Type
Observational

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communicable Diseases, Opportunistic Infections
Keywords
Communicable Infection, Monitoring, Non-Invasive Tests, Opportunistic Infection

7. Study Design

Enrollment
300 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7714198
Citation
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.
Results Reference
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PubMed Identifier
8077384
Citation
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.
Results Reference
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PubMed Identifier
1328287
Citation
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.
Results Reference
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Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy

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