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

Southwest Regional Wound Care Center

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01089153

56-RW-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.