Mycobacterium InfectionNCT01628744
Autoantibodies Against Specific Cytokines in Adults With Severe Mycobacterial Infection
An observational study of Mycobacterium Infection, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
In adult, the prevalence of mycobacterial infections is increased with age is largely unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in adult against mycobacteria. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycobacterium Infection
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pateitns with Mycobacterium, Particular to the non Tuberculosis mycobacterium infection, in Taiwan
Who may be able to join
- Patients with mycobacterial infection
Who cannot join
- Malignancy
- Severe autoimmune
- HIV infection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Graduate Institute of Clinical Medical Science, China Medical University
Taichung
Chih Y. Chi, M.D,
About this study
In adult, the prevalence of mycobacterial infections is increased with age is largely unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in adult against mycobacteria. Based on this hypothesis, the investigators had applied a functional assay to these pathways in patients with mycobacterial infection.
- Conditions
- Mycobacterium Infection
- Medical subject headings
- Mycobacterium Infections
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 |
|---|---|---|
| Patients with mycobacterial infection | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJan 2011
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium InfectionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Lung KU, Ph.D, Principal investigator, Graduate Institute of clinical Medical Science, China Medical Univerity, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628744
- Sponsor's protocol ID
- DMR-99-IRB-075-1
- Status last verified
- Jun 2012
- First submitted
- 24 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoantibodies Against Specific Cytokines in Adults With Severe Mycobacterial Infection
- ClinicalTrials.gov ID
- NCT01628744
- Acronym / sponsor ID
- DMR-99-IRB-075-1
- Conditions
- Mycobacterium Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Jun 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.
In adult, the prevalence of mycobacterial infections is increased with age is largely unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in adult against mycobacteria. Based on this hypothesis, the investigators had applied a functional assay to these pathways in patients with mycobacterial infection.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mycobacterial infection | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pateitns with Mycobacterium, Particular to the non Tuberculosis mycobacterium infection, in Taiwan
Key inclusion criteria (1 listed)
- Patients with mycobacterial infection
Key exclusion criteria (3 listed)
- Malignancy
- Severe autoimmune
- HIV infection
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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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.
Cheng-Lung KU, Ph.D principal investigator
Graduate Institute of clinical Medical Science, China Medical Univerity, Taiwan
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 Mycobacterium Infection, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-?Lung KU, Ph.D ((886) (0)3 211-8800 ext. 3496, clku@mail.cgu.edu.tw), or a site near the patient. 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 27 Jun 2012.