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NCT00764023 Clinical Trial

A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host-Microbe Scientific Study

Infections Clinical Trial

Official title:
A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune,or Host-Microbe Scientific Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00764023
Other study ID # 56-RW-010
Secondary ID
Status Completed
Phase N/A
First received September 30, 2008
Last updated November 24, 2015
Start date March 2008
Est. completion date January 2013

Study information
Verified date November 2015
Source Southwest Regional Wound Care Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.

Description:

The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. The studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16S DNA, mRNA), proteins, or other metabolites.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. The Subject must be 18 years of age or older

2. The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative.

Exclusion Criteria:

1. The Subject may not be currently incarcerated.

2. The Subject may not be knowingly pregnant.

3. The Subject may not be institutionalized.

4. The Subject may not be an employee or student of the investigator or sponsor.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Southwest Regional Wound Care Center Lubbock Texas

Sponsors (1)
Lead Sponsor Collaborator
Southwest Regional Wound Care Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

A Possible Role of Bacterial Biofilm in the Pathogenesis of Atherosclerosis Bacteriol Parasitol Volume 3 • Issue 1 • 1000127 ISSN:2155-9597 JBP an open access journal

Outcome
Type Measure Description Time frame Safety issue
Primary The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. 1 year No
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