NCT Number: NCT01089153
Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research
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.
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The subject must be able to be fully consented to the study.
- The subject must be 18 years of age or older.
- The subject must be mentally competent as determined by the Investigator.
Exclusion criteria
- The subject must not be currently incarcerated or pregnant.
- The subject must not weigh less than 110lbs.
- 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.
- If the Subject's health would be compromised by contributing up to 30ml of peripheral blood.
- If in the opinion of the Investigator, the subject has any clinically significant medical diagnosis/conditions which would prevent participation.
Sponsors and collaborators
Lead sponsor
Southwest Regional Wound Care Center
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Mar 18, 2010
- Registry last updated
- Sep 7, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.