Monitoring Patients for Developing Communicable and Oppor... | NCT00001477

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

NCT00001477

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

300

Phase

Not provided

Conditions

Communicable Diseases
Opportunistic Infections

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
95-I-0176

Status Module

Record Verification Date

Feb 2000

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1995

Primary Completion Date

Not provided

Completion Date

Oct 2000

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Dec 9, 2002

First Posted Date

Dec 10, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)NIH

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Allergy and Infectious Diseases (NIAID)		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7714198	Background	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.
8077384	Background	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.

ID	Term
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms