Pediatric multidrug-resistant tuberculosis clinical trials: challenges and opportunities

File Description SizeFormat 
1-s2.0-S1201971216316435-main.pdfPublished version364.1 kBAdobe PDFView/Open
Title: Pediatric multidrug-resistant tuberculosis clinical trials: challenges and opportunities
Authors: McAnaw, SE
Hesseling, AC
Seddon, JA
Dooley, KE
Garcia-Prats, AJ
Kim, S
Jenkins, HE
Schaaf, HS
Sterling, TR
Horsburgh, CR
Item Type: Journal Article
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.
Issue Date: 9-Dec-2016
Date of Acceptance: 30-Nov-2016
ISSN: 1201-9712
Publisher: Elsevier
Start Page: 194
End Page: 199
Journal / Book Title: International Journal of Infectious Diseases
Volume: 56
Copyright Statement: ß 2016 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (
Keywords: Science & Technology
Life Sciences & Biomedicine
Infectious Diseases
Multidrug-resistant tuberculosis
MDR tuberculosis
MDR-TB Pediatric Clinical trials
Antitubercular Agents
Clinical Trials as Topic
Tuberculosis, Multidrug-Resistant
Tuberculosis, Pulmonary
0605 Microbiology
1108 Medical Microbiology
Publication Status: Published
Appears in Collections:Department of Medicine
Faculty of Medicine

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Creative Commons