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CompletedNCT00979290Updated Apr 16, 2015

Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs

An observational study in Tuberculosis, sponsored by E-DA Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by E-DA Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
161
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Tuberculosis

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Keywords

  • Fix-dose combination anti-TB drug
  • adverse effect
  • efficiency
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 161 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

E-DA Hospital is the lead sponsor of 34 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Newly diagnosed TB patients in E-DA hospital

Inclusion criteria

  1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
  2. No previous anti-TB drugs treatment
  3. Age≥18years old

Exclusion criteria

Exclusion Criteria:

  1. Expected life \< 6months
  2. Baseline AST/ALT > 3x upper limit of normal (ULN)
  3. Age \<18years old
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
161 participants (actual)

Groups and cohorts

  • Separate anti-TB drugs
  • Fix-dosed combination anti-TB drugs
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What researchers measure

Primary outcomes

  1. To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment

    Time frame: two year

Secondary outcomes

  1. To compare the efficacy of anti-TB treatment between using FDC and single drugs

    Time frame: two year

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Study locations

1 site
  • E-DA hospital
    Kaohsiung, Taiwan
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00979290
Lead sponsor
E-DA Hospital
Responsible party
Sponsor
First posted
Sep 17, 2009
Start date
Oct 2008
Primary completion
Nov 2009
Completion
Nov 2011
Last update
Apr 16, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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