Levofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)

Autor: James A. Seddon, Anthony J. Garcia-Prats, Susan E. Purchase, Muhammad Osman, Anne-Marie Demers, Graeme Hoddinott, Angela M. Crook, Ellen Owen-Powell, Margaret J. Thomason, Anna Turkova, Diana M. Gibb, Lee Fairlie, Neil Martinson, H. Simon Schaaf, Anneke C. Hesseling
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Trials, Vol 19, Iss 1, Pp 1-11 (2018)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-018-3070-0
Popis: Abstract Background Multidrug-resistant (MDR) tuberculosis (TB) presents a challenge for global TB control. Treating individuals with MDR-TB infection to prevent progression to disease could be an effective public health strategy. Young children are at high risk of developing TB disease following infection and are commonly infected by an adult in their household. Identifying young children with household exposure to MDR-TB and providing them with MDR-TB preventive therapy could reduce the risk of disease progression. To date, no trials of MDR-TB preventive therapy have been completed and World Health Organization guidelines suggest close observation with no active treatment. Methods The tuberculosis child multidrug-resistant preventive therapy (TB-CHAMP) trial is a phase III cluster randomised placebo-controlled trial to assess the efficacy of levofloxacin in young child contacts of MDR-TB cases. The trial is taking place at three sites in South Africa where adults with MDR-TB are identified. If a child aged
Databáze: Directory of Open Access Journals
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