title: Pediatric multidrug-resistant tuberculosis clinical trials: challenges and opportunities.
abstract: On June 17, 2016, RESIST-TB, IMPAACT, Vital Strategies, and New Ventures jointly hosted the Pediatric Multidrug Resistant Tuberculosis Clinical Trials Landscape Meeting in Arlington, Virginia, USA. The meeting provided updates on current multidrug-resistant tuberculosis (MDR-TB) trials targeting pediatric populations and adult trials that have included pediatric patients. A series of presentations were given that discussed site capacity needs, community engagement, and additional interventions necessary for clinical trials to improve the treatment of pediatric MDR-TB. This article presents a summary of topics discussed, including the following: current trials ongoing and planned; the global burden of MDR-TB in children; current regimens for MDR-TB treatment in children; pharmacokinetics of second-line anti-tuberculosis medications in children; design, sample size, and statistical considerations for MDR-TB trials in children; selection of study population, design, and treatment arms for a trial of novel pediatric MDR-TB regimens; practical aspects of pediatric MDR-TB treatment trials; and strategies for integrating children into adult tuberculosis trials. These discussions elucidated barriers to pediatric MDR-TB clinical trials and provided insight into necessary next steps for progress in this field. Investigators and funding agencies need to respond to these recommendations so that important studies can be implemented, leading to improved treatment for children with MDR-TB.
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA. Electronic address: semcanaw@gmail.com.
authors.forename: S E
authors.initials: SE
authors.lastname: McAnaw
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: A C
authors.initials: AC
authors.lastname: Hesseling
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Seddon
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: K E
authors.initials: KE
authors.lastname: Dooley
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: A J
authors.initials: AJ
authors.lastname: Garcia-Prats
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: H E
authors.initials: HE
authors.lastname: Jenkins
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: H S
authors.initials: HS
authors.lastname: Schaaf
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: T R
authors.initials: TR
authors.lastname: Sterling
authors.affiliation: RESIST TB, 801 Massachusetts Avenue, suite 389, Boston, MA 202118, USA.
authors.forename: C R
authors.initials: CR
authors.lastname: Horsburgh
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic; D006801:Humans; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy* / Q000453:epidemiology; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D000995:Antitubercular Agents
keywords: MDR tuberculosis; MDR-TB Pediatric Clinical trials; Multidrug-resistant tuberculosis; Tuberculosis