Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)

The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.

Completed

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed pulmonary tuberculosis patients
Informed consent including pharmacogenomic analysis

Exclusion criteria

Abnormal liver and kidney function test before treatment
Long-term use of steroids and/or immunodepressants
Inadequate clinical conditions

Treatment and study plan

Isoniazid

Drug

Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively

isoniazed

Drug

Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all

Primary outcomes

The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
- the incidences of drug-induced liver injury associated with INH that occurred within 8 weeks of the treatments, and 2) the incidence of early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week

Secondary outcomes

Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Registry information

Important dates

Study start: 2005
First posted: Mar 3, 2006
Registry last updated: Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed