Tuberculosis, PulmonaryNCT00567151
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB
An observational study of Tuberculosis, Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Pulmonary
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Dec 2008
- 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: Patients visited Seoul National University Hospital
Who may be able to join
- New patients with pulmonary TB
- Sputum AFB smear-positivity
Who cannot join
- Non-applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Nontuberculous Mycobacterial co-Infection Using Duplex PCR for Mycobacterial Hsp 65 Gene and Its Clinical Significance in Patients With Smear Positive Pulmonary Tuberculosis
The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the clinical significance of this co-infection will be evaluated.
- Conditions
- Tuberculosis, Pulmonary
- Medical subject headings
- Tuberculosis, Pulmonary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Joon Yim, MD, Principal investigator, Seoul National Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567151
- Sponsor's protocol ID
- H-0711-022-225
- Other IDs
- Non-applicable
- Status last verified
- Jun 2009
- First submitted
- 2 Dec 2007
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Nontuberculous Mycobacterial co-Infection Using Duplex PCR for Mycobacterial Hsp 65 Gene and Its Clinical Significance in Patients With Smear Positive Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT00567151
- Acronym / sponsor ID
- H-0711-022-225
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Dec 2007 (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.
The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the clinical significance of this co-infection will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients visited Seoul National University Hospital
Key inclusion criteria (2 listed)
- New patients with pulmonary TB
- Sputum AFB smear-positivity
Key exclusion criteria (1 listed)
- Non-applicable
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 23 Jun 2009.
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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.
Jae-Joon Yim, MD principal investigator
Seoul National Univeristy Hospital
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, Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 1 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 23 Jun 2009. 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 South Korea. 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.
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 23 Jun 2009.