Adverse Reactions and Efficacy of Fixed-dose Combination... | NCT00979290

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

NCT00979290

Sponsor

E-DA Hospital

Status

Completed

Last Update Posted

Apr 16, 2015Estimated

Enrollment

161Actual

Phase

Not provided

Conditions

Tuberculosis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2011Actual

First Submitted Date

Sep 14, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2015

Last Update Posted Date

Apr 16, 2015Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment		two year

Secondary Outcomes

Measure	Description	Time Frame
To compare the efficacy of anti-TB treatment between using FDC and single drugs		two year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Expected life < 6months
Baseline AST/ALT > 3x upper limit of normal (ULN)
Age <18years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed TB patients in E-DA hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
E-DA hospital		Kaohsiung City			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26106962	Derived	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.

Label	Type	Description	Intervention Names
Separate anti-TB drugs
Fix-dosed combination anti-TB drugs

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections