TY - JOUR
T1 - Pediatric multidrug-resistant tuberculosis clinical trials
T2 - challenges and opportunities
AU - McAnaw, S. E.
AU - Hesseling, A. C.
AU - Seddon, J. A.
AU - Dooley, K. E.
AU - Garcia-Prats, A. J.
AU - Kim, S.
AU - Jenkins, H. E.
AU - Schaaf, H. S.
AU - Sterling, T. R.
AU - Horsburgh, C. R.
N1 - Publisher Copyright:
© 2016 The Author(s)
PY - 2017/3/1
Y1 - 2017/3/1
N2 - 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.
AB - 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.
KW - MDR tuberculosis
KW - MDR-TB Pediatric Clinical trials
KW - Multidrug-resistant tuberculosis
KW - Tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=85009279019&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85009279019&partnerID=8YFLogxK
U2 - 10.1016/j.ijid.2016.11.423
DO - 10.1016/j.ijid.2016.11.423
M3 - Review article
C2 - 27955992
AN - SCOPUS:85009279019
SN - 1201-9712
VL - 56
SP - 194
EP - 199
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
ER -