ISRCTN63327174已完成不适用

Effect of community-wide isoniazid preventive therapy on tuberculosis among South African gold miners (Thibela TB)

Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)0 个研究点目标入组 70,000 人开始时间: 2006年6月1日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•All employees working within the study clusters are eligible for participation in the study as a whole, there are no specific exclusion criteria. Employees at clusters allocated to the intervention will be eligible for isoniazid preventive therapy.

•1. Active TB (confirmed or suspected)
•2. Weight less than 40 kg
•3. Known or suspected hypersensitivity to isoniazid (INH)
•4. Self-reported chronic liver disease or symptoms suggesting active hepatitis (jaundice, nausea, vomiting, right upper quadrant pain, dark urine, pale stools)
•5. Alcohol use exceeding 28 units per week (men) or 21 units per week (women)
•6. History of convulsions
•7. History of psychosis
•8. Peripheral neuropathy grade 2 or greater, as defined by the aquired immune deficiency syndrome (AIDS) clinical trials group classification of adverse events
•9. Pregnancy and up to three months post-partum, or breastfeeding
•10. Women of child bearing potential who decline to use contraception
•11. Receipt of another investigational drug or product within the previous 30 days
•12. Concomitant medication with phenytoin, carbamazepine, warfarin, theophylline, disulfiram, selective serotonin re-uptake inhibitor antidepressants (e.g. citalopram, fluoxetine, paroxetine, sertraline), oral ketoconazole or itraconazole

发起方

Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)