Woman and Man
- | Country : -
- | organs : -
- | Specialty : -
Extract
Background and study aims Of the estimated 9 million tuberculosis (TB) cases globally annually, more than half a million are in children. This burden is highest in Africa and South East Asia and results in 100,000 deaths each year. Regimens for prevention and treatment of TB in children have lagged considerably behind those for adults. This is likely because children usually present with 'minimal' (i.e. smear-negative and less severe) disease. Therefore TB in children is very difficult to diagnose and children are rarely infectious, posing little risk of onward transmission. Current TB treatment (for both adults and children) involves six months of treatment: a two month intensive phase of three or four drugs, followed by a maintenance phase lasting four months. Historically, the doses of drugs prescribed to children have been based on a weight-based scaling-down of the adult dose, resulting in uncertainty over the correct paediatric dose. In 2010, the WHO revised their dose recommendations for anti-TB drugs for children, and now recommends higher doses of many of the commonly used drugs. Based on this dose increase, the SHINE study wants to find out if the standard 6 month regimen can be reduced to 4 months. Who can participate? Children under 16 with suspected minimal TB disease (with or without HIV infection) will be screened. A total of 1,200 children will be recruited. What does the study involve? A screening visit involving TB tests (skin test and sputum sample), an X-ray and blood tests will be carried out to confirm that the child is eligible. Consenting participants will then be randomly allocated to either the 4-month regimen or the 6-month regimen. Enough anti-TB drugs will be prescribed for the child to take daily until they are seen at their next clinic visit. Visits will be monthly whilst taking the medication, and then every three months. At each visit, details of the child's health, height and weight will be recorded, as well as information about how well children take their medicines and if there are any particular problems taking them. At some visits, blood, urine and hair samples will be collected for storage and future testing. What are the possible benefits and risks of participating? There may be no direct benefit to the children participating in the SHINE study. However, the information we get from this study will help to improve treatment for children with TB in the future. These children need to be treated for TB regardless of whether or not they participate in the SHINE study, and treatment has risks and side effects. The common side effects of anti-TB drugs are red tears, red urine, joint pains and injury to the liver. Participating children will also need to attend the clinic more frequently than if they were receiving treatment outside of the SHINE study. In addition there will be some extra blood tests. Where is the study run from? 4 sites: - South Africa: Stellenbosch University, Cape Town (target recruitment: 250 children) - India: National Institute for Research in Tuberculosis, Chennai and BJ Medical College, Pune (target recruitment: 450 children) - Uganda: MU-JHU Care Ltd, Kampala (target recruitment: 250 children) - Zambia: University Teaching Hospital, Lusaka (target recruitment: 250 children) Coordinated from MRC Clinical Trials Unit at UCL, London, UK. When is the study starting and how long is it expected to run for? The total duration of the study will be 48 months, as follows: 6 months start-up, 18 months enrolment, follow-up until the last patient has reached 18 months, and a further 6 months for close-out and analysis. - Anticipated start date of recruitment: Q2 2015. - Anticipated end date of recruitment: Q4 2016. - Anticipated study end date: Q2 2019. Who is funding the study? SHINE is funded by the Joint Global Health Trials Scheme: Department for International Development, the Wellcome Trust, the Medical Research Council and Svizera Ltd. Who is the main contact? SHINE Trial Management Team MRC Clinical Trials Unit at UCL Institute of Clinical Trials and Methodology Aviation House, 125 Kingsway, London WC2B 6NH, UK +44 (0) 20 7670 4700 [email protected]
Inclusion criteria
- Paediatric tuberculosis (minimal TB)