Ganguly, Samit http://orcid.org/0000-0002-3037-1959
Edginton, Andrea N.
Gerhart, Jacqueline G. http://orcid.org/0000-0003-4679-4638
Cohen-Wolkowiez, Michael http://orcid.org/0000-0002-2458-2266
Greenberg, Rachel G.
Gonzalez, Daniel http://orcid.org/0000-0001-5522-5686
Benjamin Jr, Daniel K.
Hornik, Christoph
Zimmerman, Kanecia
Kennel, Phyllis
Beci, Rose
Hornik, Chi Dang
Kearns, Gregory L.
Laughon, Matthew
Paul, Ian M.
Sullivan, Janice
Wade, Kelly
Delmore, Paula
Taylor-Zapata, Perdita
Lee, June
Anand, Ravinder
Sharma, Gaurav
Simone, Gina
Kaneshige, Kim
Taylor, Lawrence
Green, Thomas
Kantak, Anand
Ohlinger, Judy
Horgan, Mike
Boynton, Susan
Eichenwald, Eric C.
Jones, Karen
Durand, David J.
Asselin, Jeanette
Arrieta, Antonio
Shea, Kathy
Wade, Kelly
Morrison, Tonia
Brozanski, Beverly S.
Baker, Robyn
Weitkamp, Joern-Hendrik
Nannie, Millie
Sanchez, Pablo
Montanye, Shirley
van den Anker, John
Williams, Elaine
Smith, P. Brian
Cohen-Wolkowiez, Michael http://orcid.org/0000-0002-2458-2266
Bidegain, Margarita
Benjamin Jr, Daniel K.
Grimes, Sandy
MacKendrick, William
Wolf, Sue
Poindexter, Brenda
Wilson, Leslie Dawn
Castro, Lisa M.
Harris, Ann
Balaraman, Venkataraman
Morse, Robyn
Rasmussen, Maynard
Arnell, Kathy
Valencia, Gloria
Higgerson, Sara
Walsh, Michele
Zadell, Arlene
Roane, Claire M.
Finer, Neil
Capparelli, Edmund V.
Rich, Wade
Burchfield, David
Miller, Cindy
Sullivan, Janice E.
Pierce, Gwendolyn
Bhatt-Mehta, Varsha
Dechert, Ron
Ward, Robert M.
Narus, JoAnn
Bizzaro, Mathew
Konstantino, Monica
,
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23HD083465, HHSN275201000003I)
National Institute of General Medical Sciences (T32GM122741)
American Foundation for Pharmaceutical Education
Article History
Accepted: 1 June 2021
First Online: 22 June 2021
Declarations
:
: This work was funded under the National Institute of Child Health and Human Development contract (HHSN275201000003I) for the Pediatric Trials Network (principal investigator Danny Benjamin). JGG received research support from a National Institute of General Medical Sciences funded T32 program (T32GM122741), as well as the American Foundation for Pharmaceutical Education. DG received research support from the National Institute of Child Health and Human Development (K23HD083465, R01HD096435, and HHSN275201000003I). The Best Pharmaceuticals for Children Act Data Coordinating Center was funded under HHSN275201700002C (principal investigator: Ravinder Anand). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
: Michael Cohen-Wolkowiez receives support for research from the National Institutes of Health (1U24-MD016258), National Institute of Allergy and Infectious Diseases (HHSN272201500006I, HHSN272201300017I, 1K24-AI143971), National Institute of Child Health and Human Development (HHSN275201000003I), US Food and Drug Administration (5U18-FD006298), and industry for drug development in adults and children. Samit Ganguly, Andrea N. Edginton, Jacqueline G. Gerhart, Rachel G. Greenberg, and Daniel Gonzalez have no conflicts of interest that are directly relevant to the content of this article.
: For the study protocol that allowed the collection of the PK data from infants with a suspected or confirmed intra-abdominal infection (ClinicalTrials.gov #NCT00621192), institutional review board approval was obtained at each participating site. For the PBPK analyses described in this publication, the Office of Human Research Ethics at the University of North Carolina at Chapel Hill determined that the research did not constitute human subjects research as defined under federal regulations [45 CFR 46.102 (d or f) and 21 CFR 56.102(c)(e)(l)] and did not require institutional review board approval.
: For the original study in infants with a suspected or confirmed intra-abdominal infection (ClinicalTrials.gov #NCT00621192), written permission (informed consent) was obtained from the parent or legal guardian.
: Not applicable.
: Meropenem infant PK data were accessed through the Eunice Kennedy Shriver National Institute of Child Health and Human Development Data and Specimen Hub (ExternalRef removed).
: Not applicable.
: SG and DG designed and performed the research; SG and JGG analyzed the data; SG, ANE, JGG, MC-W, RGG, and DG wrote or contributed to the writing of the manuscript.