The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne SpirochaetesNCT01089153
Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research
An observational study of The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne Spirochaetes, run by Southwest Regional Wound Care Center.
Trial summary
Current spirochaete infection identification and diagnostic strategies have important limitations. Recent development may allow for an improvement in diagnostic, screening and survey capabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne Spirochaetes
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Keywords
- human blood, urine and fecal samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne SpirochaetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
- Investigators
- Randall Wolcott, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089153
- Sponsor's protocol ID
- 56-RW-015
- Status last verified
- Sep 2011
- First submitted
- 16 Mar 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research
- ClinicalTrials.gov ID
- NCT01089153
- Acronym / sponsor ID
- 56-RW-015
- Keywords
- human blood, urine and fecal samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Wolcott, MD principal investigator
Southwest Regional Wound Care Center
Questions about this trial
What is this clinical trial studying?
An observational study of The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne Spirochaetes, run by Southwest Regional Wound Care Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.