TuberculosisPhase 3LTBI_prisonNCT00767975
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
A Phase 3 study testing isoniazid , randomized, open label and rifampin, randomized, open label in people with Tuberculosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
LTBI Treatment is effective in prison Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Tuberculosis
- What is being tested?
- isoniazid , randomized, open label and rifampin, randomized, open label
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,384 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Nov 2010
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all people who is LTBI, and have ability to sign the informed concent
Who cannot join
- previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT > 3 times of normal limit platelet < 150 k/mm3 T-bil > 2 times of normal limit
Trial locations and contacts
1 site in 1 country.
About this study
LTBI Treatment is effective in prison
Read the detailed description
LTBI treatment will be conducted in a prison with either isoniazid or rifampin
- Conditions
- Tuberculosis
- Being tested
- isoniazid , randomized, open label, rifampin, randomized, open label
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isoniazid , randomized, open labelDrug
isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)
rifampin, randomized, open labelDrug
rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | For patients who diagnosed with LTBI, they choose to receive LTBI treatment depends on their willingness; if they choose not, then they are in no intervention arm. |
| 1 | Experimental | Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness Receives: Drug: isoniazid , randomized, open label; Drug: rifampin, randomized, open label |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPLETE RATE OF LTBI TREATMENT
Measured: 1.5 year
Secondary outcomes (1)
Efficacy
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,384 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Li-Min Huang, MD, PHD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767975
- Sponsor's protocol ID
- 200707047M
- Other IDs
- DOH-97-DC-1502
- Acronym
- LTBI_prison
- Status last verified
- Nov 2010
- First submitted
- 10 Jan 2008
- Last updated
- 29 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan PC, Yang CH, Chang LY, Wang KF, Lu BY, Lu CY, Shao PL, Hsueh PR, Fang CT, Huang LM. Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial. Int J Tuberc Lung Dis. 2012 May;16(5):633-8. doi: 10.5588/ijtld.11.0504. Epub 2012 Mar 8.
PubMed 22410137
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
- ClinicalTrials.gov ID
- NCT00767975
- Acronym / sponsor ID
- LTBI_prison / 200707047M
- Conditions
- Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,384 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Oct 2008 (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.
LTBI Treatment is effective in prison
Detailed description
LTBI treatment will be conducted in a prison with either isoniazid or rifampin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –For patients who diagnosed with LTBI, they choose to receive LTBI treatment depends on their willingness; if they choose not, then they are in no intervention arm. |
| 1 | Experimental | Drug: isoniazid , randomized, open label, Drug: rifampin, randomized, open labelProvided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all people who is LTBI, and have ability to sign the informed concent
Key exclusion criteria (1 listed)
- previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT > 3 times of normal limit platelet < 150 k/mm3 T-bil > 2 times of normal limit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isoniazid , randomized, open labelisoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin) | Drug | 1 |
| rifampin, randomized, open labelrifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid) | Drug | 1 |
Primary outcome
COMPLETE RATE OF LTBI TREATMENT
Time frame: 1.5 year
1 secondary outcome
Efficacy
Time frame: 3 year
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 29 Nov 2010.
- Derived from this study: PubMed 22410137Chan PC, Yang CH, Chang LY, Wang KF, Lu BY, Lu CY, Shao PL, Hsueh PR, Fang CT, Huang LM. Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial. Int J Tuberc Lung Dis. 2012 May;16(5):633-8. doi: 10.5588/ijtld.11.0504. Epub 2012 Mar 8.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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.
Li-Min Huang, MD, PHD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing isoniazid , randomized, open label and rifampin, randomized, open label in people with Tuberculosis, run by National Taiwan 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 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 29 Nov 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
COMPLETE RATE OF LTBI TREATMENT (time frame: 1.5 year). 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 NCT00767975, which also lists 1 linked publication.
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 29 Nov 2010.