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

Tuberculosis Clinical Trial

Official title:

Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979290
• Other study ID #: J120114933
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: April 14, 2015
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: November 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Newly diagnosed pulmonary TB and extrapulmonary TB patients

2. No previous anti-TB drugs treatment

3. Age=18years old

Exclusion Criteria:

1. Expected life < 6months

2. Baseline AST/ALT > 3x upper limit of normal (ULN)

3. Age <18years old

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Taiwan	E-DA hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment		two year	Yes
Secondary	To compare the efficacy of anti-TB treatment between using FDC and single drugs		two year	No