TuberculosisNCT00979290
Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs
An observational study of Tuberculosis, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 161 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2008to Nov 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed TB patients in E-DA hospital
Who may be able to join
- Newly diagnosed pulmonary TB and extrapulmonary TB patients
- No previous anti-TB drugs treatment
- Age≥18years old
Who cannot join
- Expected life < 6months
- Baseline AST/ALT > 3x upper limit of normal (ULN)
- Age <18years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis
The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.
- Conditions
- Tuberculosis
- Keywords
- Fix-dose combination anti-TB drug, adverse effect, efficiency
- 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 |
|---|---|---|
| Separate anti-TB drugs | Not described | |
| Fix-dosed combination anti-TB drugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
Measured: two year
Secondary outcomes (1)
To compare the efficacy of anti-TB treatment between using FDC and single drugs
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionNov 2011
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979290
- Sponsor's protocol ID
- J120114933
- Status last verified
- Apr 2015
- First submitted
- 14 Sep 2009
- Last updated
- 16 Apr 2015
- Results posted
- No
Publications
Wu JT, Chiu CT, Wei YF, Lai YF. Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment. Clinics (Sao Paulo). 2015 Jun;70(6):429-34. doi: 10.6061/clinics/2015(06)08. Epub 2015 Jun 1.
PubMed 26106962
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT00979290
- Acronym / sponsor ID
- J120114933
- Conditions
- Tuberculosis
- Keywords
- Fix-dose combination anti-TB drug, adverse effect, efficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Sep 2009 (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 fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Separate anti-TB drugs | – | – |
| Fix-dosed combination anti-TB drugs | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed TB patients in E-DA hospital
Key inclusion criteria (3 listed)
- Newly diagnosed pulmonary TB and extrapulmonary TB patients
- No previous anti-TB drugs treatment
- Age≥18years old
Key exclusion criteria (3 listed)
- Expected life < 6months
- Baseline AST/ALT > 3x upper limit of normal (ULN)
- Age <18years old
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
To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
Time frame: two year
1 secondary outcome
To compare the efficacy of anti-TB treatment between using FDC and single drugs
Time frame: two 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 16 Apr 2015.
- Derived from this study: PubMed 26106962Wu JT, Chiu CT, Wei YF, Lai YF. Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment. Clinics (Sao Paulo). 2015 Jun;70(6):429-34. doi: 10.6061/clinics/2015(06)08. Epub 2015 Jun 1.
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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 E-DA 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 3 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: finished, as of the sponsor's last update on 16 Apr 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 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?
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?
To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment (time frame: two 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 NCT00979290, 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 16 Apr 2015.