Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT01089153
First received: March 16, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

Current spirochaete infection identification and diagnostic strategies have important limitations. Recent development may allow for an improvement in diagnostic, screening and survey capabilities. The goal of this study is to evaluate blood, urine and fecal samples from a variety of sources and generate information on the occurrence and epidemiology of spirochetes in the general and at risk populations.


Condition
The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne Spirochaetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research

Resource links provided by NLM:


Further study details as provided by Southwest Regional Wound Care Center:

Biospecimen Retention:   Samples With DNA

human blood, urine and fecal samples


Enrollment: 35
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The intent of this protocol is to obtain blood, feces and urine samples from subjects with or without a suspected spirochaete infection, so these samples can be used in spirochaete-related scientific studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Blood, feces and urine samples may be collected from subjects with known or suspected spirochetal disease or from subjects not suspected to be infected with spirochetes

Criteria

Inclusion Criteria:

  1. The subject must be able to be fully consented to the study.
  2. The subject must be 18 years of age or older.
  3. The subject must be mentally competent as determined by the Investigator.

Exclusion Criteria:

  1. The subject must not be currently incarcerated or pregnant.
  2. The subject must not weigh less than 110lbs.
  3. If the subject will be contributing more that 60 ml of blood during an 8 (eight) week period, then the subject must not have donated red blood cells within the last 8 (eight) weeks.
  4. If the Subject's health would be compromised by contributing up to 30ml of peripheral blood.
  5. If in the opinion of the Investigator, the subject has any clinically significant medical diagnosis/conditions which would prevent participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089153

Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
Principal Investigator: Randall Wolcott, MD Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Randall Wolcott, Prinicipal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT01089153     History of Changes
Other Study ID Numbers: 56-RW-015
Study First Received: March 16, 2010
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
human blood, urine and fecal samples

ClinicalTrials.gov processed this record on April 15, 2014