TuberculosisNCT01585532
Alere Mycobacterium Tuberculosis Urine Study
An observational study of Tuberculosis, run by Research Center Borstel at 1 site in Germany.
Trial summary
Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2013
- 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: Patients with suspected or confirmed tuberculosis
Who may be able to join
- Suspected or confirmed tuberculosis
- Age >18 years
- informed consent obtained
Who cannot join
- Previous participation in the study
- Simultaneous participation in a clinical trial investigating a new drug
- Inability to give consent
- Member of a vulnerable study population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid
Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Urine, Nucleic acid, Alere, Borstel
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TB suspects with alternative final diagnosis | Not described | |
| Confirmed tuberculosis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
ROC analysis to determine the best specificity and sensitivity to differentiate between patients with tuberculosis and patients with an alternative diagnosis
Measured: On admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Collaborators
- Alere Technologies GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585532
- Sponsor's protocol ID
- RCBorstel002
- Other IDs
- CLDG-0402
- Status last verified
- Nov 2015
- First submitted
- 13 Apr 2012
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid
- ClinicalTrials.gov ID
- NCT01585532
- Acronym / sponsor ID
- RCBorstel002
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Urine, Nucleic acid, Alere, Borstel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Collaborators
- Alere Technologies GmbH
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Apr 2012 (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 molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB suspects with alternative final diagnosis | – | – |
| Confirmed tuberculosis patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or confirmed tuberculosis
Key inclusion criteria (3 listed)
- Suspected or confirmed tuberculosis
- Age >18 years
- informed consent obtained
Key exclusion criteria (4 listed)
- Previous participation in the study
- Simultaneous participation in a clinical trial investigating a new drug
- Inability to give consent
- Member of a vulnerable study population
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
Sensitivity and specificity
Time frame: On admission to hospital
ROC analysis to determine the best specificity and sensitivity to differentiate between patients with tuberculosis and patients with an alternative diagnosis
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 5 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Research Center Borstel at 1 site in Germany.
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 4 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 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Sensitivity and specificity (time frame: On admission to hospital). It is what the study was designed to measure, not a finding.
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 5 Nov 2015.