Tuberculosis Child Multidrug-resistant Preventive Therapy Trial
Will treating children living with an adult who had or has MDR-TB (Multi-drug resistant Tuberculosis) with a drug called levofloxacin reduce their risk of developing TB compared to treatment with an inactive drug (placebo)?
What is this study about?
People who have shared the same home with a person with MDR-TB may have become infected with the TB bacterium. People who are infected with the TB bacterium are generally well but it may, however, start to grow and attack the body and make people sick. In people who are well but are infected with the TB bacterium, we can treat the TB bacterium with a medicine called isoniazid to stop it from making people sick with TB. A TB bacterium that does not respond to treatment can possibly be treated with another medicine called levofloxacin taken daily for six months. In this study, we want to see whether the drug levofloxacin prevents MDR-TB disease in children who are living with a person who has MDR-TB.
Type of study
Who is funding the study?
TB-CHAMP is funded by Joint Global Health Trials Scheme of the Department for International Development, UK (DFID), The Wellcome Trust and The Medical Research Council (MRC UK), Grant number MR/M007340/1 and the South African Medical Research Council. Stellenbosch University, South Africa is the trial sponser and has delegated responsibility for the overall management of the TB-CHAMP trial to the MRC CTU.
When is it taking place?
The trial started in September 2017, recruitment and follow up are expected to be completed by 2020
Where is it taking place?
South Africa - Cape Town, Johannesburg and Matlosana
Who is included?
Children less than 5 years old that share the same home with an adult that has MDR-TB.