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)

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dc.contributor.authorSeddon, James A.en_ZA
dc.contributor.authorGarcia-Prats, Anthony J.en_ZA
dc.contributor.authorPurchase, Susan E.en_ZA
dc.contributor.authorOsman, Muhammaden_ZA
dc.contributor.authorDemers, Anne-Marieen_ZA
dc.contributor.authorHoddinott, Graemeen_ZA
dc.contributor.authorCrook, Angela M.en_ZA
dc.contributor.authorOwen-Powell, Ellenen_ZA
dc.contributor.authorThomason, Margaret J.en_ZA
dc.contributor.authorTurkova, Annaen_ZA
dc.contributor.authorGibb, Diana M.en_ZA
dc.contributor.authorFairlie, Leeen_ZA
dc.contributor.authorMartinson, Neilen_ZA
dc.contributor.authorSchaaf, H. Simonen_ZA
dc.contributor.authorHesseling, Anneke C.en_ZA
dc.date.accessioned2019-01-15T13:40:24Z
dc.date.available2019-01-15T13:40:24Z
dc.date.issued2018-12-20
dc.date.updated2019-01-15T11:49:39Z
dc.descriptionCITATION: Seddon, J. A., et al. 2018. 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). Trials, 19:693, doi:10.1186/s13063-018-3070-0.
dc.descriptionThe original publication is available at https://trialsjournal.biomedcentral.com
dc.description.abstractBackground: 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 < 5 years lives in their household, we assess the adult index case, screen all household members for TB disease and evaluate any child aged < 5 years for trial eligibility. Eligible children are randomised by household to receive daily levofloxacin (15–20 mg/kg) or matching placebo for six months. Children are closely monitored for disease development, drug tolerability and adverse events. The primary endpoint is incident TB disease or TB death by one year after recruitment. We will enrol 1556 children from approximately 778 households with an average of two eligible children per household. Recruitment will run for 18–24 months with all children followed for 18 months after treatment. Qualitative and health economic evaluations are embedded in the trial. Discussion: If the TB-CHAMP trial demonstrates that levofloxacin is effective in preventing TB disease in young children who have been exposed to MDR-TB and that it is safe, well tolerated, acceptable and cost-effective, we would expect that that this intervention would rapidly transfer into policy.
dc.description.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3070-0
dc.description.versionPublisher's version
dc.format.extent11 pages ; illustrations
dc.identifier.citationSeddon, J. A., et al. 2018. 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). Trials, 19:693, doi:10.1186/s13063-018-3070-0
dc.identifier.issn1745-6215 (online)
dc.identifier.otherdoi:10.1186/s13063-018-3070-0
dc.identifier.urihttp://hdl.handle.net/10019.1/105326
dc.publisherBMC (part of Springer Nature)
dc.rights.holderAuthors retain copyright
dc.subjectTuberculosis in children -- Prevention -- South Africaen_ZA
dc.subjectMultidrug-resistant tuberculosis -- Prevention -- South Africaen_ZA
dc.subjectTB-CHAMP trial -- South Africaen_ZA
dc.subjectLevofloxacin -- Testing -- South Africaen_ZA
dc.subjectClinical trials -- South Africaen_ZA
dc.titleLevofloxacin 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)en_ZA
dc.typeArticleen_ZA
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