TuberculosisNCT01601275
Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection
An observational study of Tuberculosis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Prospective data collection of all patients with microbiologically proven mycobacteria tuberculosis infection treated at Singapore General Hospital. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 4,600 participants
- Where
- 1 siteSingapore
- Study dates
- May 2012to May 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with microbiologically proven mycobacteria tuberculosis infection treated at the Singapore General Hospital.
Who may be able to join
- 1) All patients with microbiologically proven mycobacteria tuberculosis infection treated at the Singapore General Hospital.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection Treated at Singapore General Hospital
Prospective data collection of all patients with microbiologically proven mycobacteria tuberculosis infection treated at Singapore General Hospital.
Read the detailed description
Tuberculosis currently infects one third of the world's population and is responsible for killing approximately 2 million individuals annually. This is a major public health concern worldwide, and there has been a huge impetus to implement strategies for better tuberculosis control.
The investigators have established a system to track all patients with microbiologically proven tuberculosis treated at Singapore General Hospital, with vigilant recording and reporting systems, from the first instance when patients were diagnosed to the time they have completed anti-tuberculosis chemotherapy. The investigators endeavour to use this system to improve patient care by adopting patient-supportive approaches that lead to high compliance rates and best possible outcomes of treatment.
- Conditions
- Tuberculosis
- Keywords
- tuberculosis
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Final outcomes of patients who have been diagnosed with microbiologically proven mycobacteria tuberculosis infection at Singapore General Hospital
Measured: From diagnosis to final outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- Prospective
- Enrolment
- 4,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Su Ying Low, BMBCh, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601275
- Sponsor's protocol ID
- 2005/060/CTBdatabase
- Status last verified
- May 2019
- First submitted
- 15 May 2012
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dye C, Watt CJ, Bleed DM, Hosseini SM, Raviglione MC. Evolution of tuberculosis control and prospects for reducing tuberculosis incidence, prevalence, and deaths globally. JAMA. 2005 Jun 8;293(22):2767-75. doi: 10.1001/jama.293.22.2767.
PubMed 15941807DeAngelis CD, Flanagin A. Tuberculosis--a global problem requiring a global solution. JAMA. 2005 Jun 8;293(22):2793-4. doi: 10.1001/jama.293.22.2793. No abstract available.
PubMed 15941812
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection Treated at Singapore General Hospital
- ClinicalTrials.gov ID
- NCT01601275
- Acronym / sponsor ID
- 2005/060/CTBdatabase
- Conditions
- Tuberculosis
- Keywords
- tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,600 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 May 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.
Prospective data collection of all patients with microbiologically proven mycobacteria tuberculosis infection treated at Singapore General Hospital.
Detailed description
Tuberculosis currently infects one third of the world's population and is responsible for killing approximately 2 million individuals annually. This is a major public health concern worldwide, and there has been a huge impetus to implement strategies for better tuberculosis control.
The investigators have established a system to track all patients with microbiologically proven tuberculosis treated at Singapore General Hospital, with vigilant recording and reporting systems, from the first instance when patients were diagnosed to the time they have completed anti-tuberculosis chemotherapy. The investigators endeavour to use this system to improve patient care by adopting patient-supportive approaches that lead to high compliance rates and best possible outcomes of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with microbiologically proven mycobacteria tuberculosis infection treated at the Singapore General Hospital.
Key inclusion criteria (1 listed)
- 1) All patients with microbiologically proven mycobacteria tuberculosis infection treated at the Singapore General Hospital.
Key exclusion criteria (0 listed)
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
Final outcomes of patients who have been diagnosed with microbiologically proven mycobacteria tuberculosis infection at Singapore General Hospital
Time frame: From diagnosis to final outcome
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 15 May 2019.
- Background: PubMed 15941807Dye C, Watt CJ, Bleed DM, Hosseini SM, Raviglione MC. Evolution of tuberculosis control and prospects for reducing tuberculosis incidence, prevalence, and deaths globally. JAMA. 2005 Jun 8;293(22):2767-75. doi: 10.1001/jama.293.22.2767.
- Background: PubMed 15941812DeAngelis CD, Flanagin A. Tuberculosis--a global problem requiring a global solution. JAMA. 2005 Jun 8;293(22):2793-4. doi: 10.1001/jama.293.22.2793. No abstract available.
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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.
Su Ying Low, BMBCh principal investigator
Singapore General 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, run by Singapore General Hospital at 1 site in Singapore.
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 0 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 15 May 2019. 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 Singapore. 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?
Final outcomes of patients who have been diagnosed with microbiologically proven mycobacteria tuberculosis infection at Singapore General Hospital (time frame: From diagnosis to final outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601275, which also lists 2 linked publications.
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 15 May 2019.