Can Latent Tuberculosis Infection (LTBI) in Recent Migrants be Treated Effectively and Safely in Primary Care? A Cluster Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Completion of Latent Tuberculosis Treatment
研究概览
简要总结
This study investigates whether recent migrants to the United Kingdom are more likely to complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB clinic.
详细描述
People with dormant/latent TB (LTBI) have TB bacteria in their bodies, but do not have any symptoms because the bacteria are not active. The investigators know that recent migrants with LTBI from countries where TB is very common (incidence greater than 150 per 100 000) are at risk of developing active TB (their dormant bacteria become active) after they arrive in the UK. Active TB can be both infectious and deadly. The treatment for LTBI is three-month course of antibiotics. This significantly reduces the risk of developing active TB. This treatment is currently arranged and supervised by hospital clinics, however, many migrants do not attend and numbers of people completing antibiotics is low. This leaves many at risk of developing active TB. This study investigates whether a community (primary care) based approach to the treatment of LTBI, coordinated by general practices and local pharmacists, will achieve higher rates of antibiotic completion. The London Borough of Newham, in the UK, has amongst the highest rates of active TB in Western Europe. As part of a strategy to tackle this disease burden, an innovative model of care has been implemented in the borough in which GPs and pharmacists screen and treat migrants with LTBI. Our trial will evaluate whether primary care based management of LTBI leads to higher rates of treatment completion amongst recent migrants when compared to hospital based care. This approach would save money (both for the health service and for patients in terms of travels costs) and reduce numbers of new cases of active TB.
The treatment for Latent Tuberculosis Infection will be 3 months of combined oral Rifampicin and Isoniazid with Pyridoxine. The dosage is weight dependent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with LTBI aged 16-35 and who have entered the UK less than 5 years ago from a country with a TB incidence of greater than 150/100,
- •Latent Tuberculosis is defined as a positive IGRA test without any symptoms or physical signs of active Tuberculosis and no evidence of active Tuberculosis on Chest X-ray.
排除标准
- •Pregnant or breastfeeding women
- •Patients requiring medications that cannot be safely taken with Rifinah
- •HIV infection.
- •Individuals with known liver disease, or abnormal liver function tests (LFTs)
- •Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)
- •Chronic or active hepatitis B or hepatitis C virus infection
- •Previous treatment for TB or LTBI.
- •Individuals who are unable to consent or who would usually be offered LTBI treatment under DOT because of their mental or social disabilities or those with drug or alcohol abuse
- •Evidence of active TB
结局指标
主要结局
Completion of Latent Tuberculosis Treatment
时间窗: 3 months
Based on patients taking at least 90 percent of doses of Rifinah during 3 months of treatment.
次要结局
- Complete of Latent Tuberculosis Treatment(3 months)
- Active Tuberculosis(2 years)
- Patient Satisfaction(3 months)
- Adverse Effects of Treatment(3 months)
- Patient Knowledge(3 months)
- Adherence to Treatment(3 months)
- Acceptability of Treatment(3 months)
- Cost-effectiveness of Treatment(2 years)