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3. Pharmacokinetics and safety of a single dose of telavancin in pediatric subjects 2-17 years of age.

Author

Goldman, Jennifer, James, Laura, Kaelin, Byron, Gibson, Breanne, Arrieta, Antonio, and Bradley, John

Subjects
antimicrobial agents, clinical therapeutics, pediatric drug therapy, pharmacokinetics
Abstract

Antimicrobial resistance increases infection morbidity in both adults and children, necessitating the development of new therapeutic options. Telavancin, an antibiotic approved in the United States for certain bacterial infections in adults, has not been examined in pediatric patients. The objectives of this study were to evaluate the short-term safety and pharmacokinetics (PK) of a single intravenous infusion of telavancin in pediatric patients. Single-dose safety and PK of 10 mg/kg telavancin was investigated in pediatric subjects >12 months to ≤17 years of age with known or suspected bacterial infection. Plasma was collected up to 24-h post-infusion and analyzed for concentrations of telavancin and its metabolite for noncompartmental PK analysis. Safety was monitored by physical exams, vital signs, laboratory values, and adverse events following telavancin administration. Twenty-two subjects were enrolled: 14 subjects in Cohort 1 (12-17 years), 7 subjects in Cohort 2 (6-11 years), and 1 subject in Cohort 3 (2-5 years). A single dose of telavancin was well-tolerated in all pediatric age cohorts without clinically significant effects. All age groups exhibited increased clearance of telavancin and reduced exposure to telavancin compared to adults, with mean peak plasma concentrations of 58.3 µg/mL (Cohort 1), 60.1 µg/mL (Cohort 2), and 53.1 µg/mL (Cohort 3). A 10 mg/kg dose of telavancin was well tolerated in pediatric subjects. Telavancin exposure was lower in pediatric subjects compared to adult subjects. Further studies are needed to determine the dose required in phase 3 clinical trials in pediatrics.

Published
2023

4. COVID-19 Disruptions: Attainment Gaps and Primary School Responses. Research Report

Author

Education Endowment Foundation (EEF) (United Kingdom), Weidmann, Ben, Allen, Rebecca, Bibby, Dave, Coe, Rob, James, Laura, Plaister, Natasha, and Thomson, Dave

Abstract

The study uses data from five assessment points for reading and maths. It focuses on a constant sample of students, all of whom completed a Rising Stars assessment in 2019 prior to the COVID-19 pandemic. The study also administered three teacher surveys: the first focused on the initial period of lockdown, the second focused on the autumn 2020 term when students returned to face-to-face instruction, the third focused on the second period of school closures from January to March 2021. This descriptive, longitudinal study focuses on primary schools in England. It has three aims: (1) to quantify changes in attainment gaps since the onset of COVID-19: the focus is on gaps between economically disadvantaged pupils and their peers in Years 2 to 6; (2) to describe how teachers and schools responded to the challenges of COVID-19; and (3) to explore associations between school responses to COVID and changes in attainment gaps. [The report was published with FFT and Teacher Tapp.]

Published
2022

8. Two SARS-CoV-2 Genome Sequences of Isolates from Rural U.S. Patients Harboring the D614G Mutation, Obtained Using Nanopore Sequencing

Author

Jenjaroenpun, Piroon, Wanchai, Visanu, Ono-Moore, Kikumi D, Laudadio, Jennifer, James, Laura P, Adams, Sean H, Prior, Fred, Nookaew, Intawat, Ussery, David W, and Wongsurawat, Thidathip

Subjects
Vaccine Related, Genetics, Pneumonia & Influenza, Lung, Bioengineering, Pneumonia, Nanotechnology, Human Genome, Biotechnology, Prevention, Good Health and Well Being
Abstract

Two coding-complete sequences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were obtained from samples from two patients in Arkansas, in the southeastern corner of the United States. The viral genome was obtained using the ARTIC Network protocol and Oxford Nanopore Technologies sequencing.

Published
2021

9. Child and caregiver perspectives on access to psychosocial and educational support in pediatric chronic kidney disease: a focus group study

Author

Zhang, Yifan, Gutman, Talia, Tong, Allison, Craig, Jonathan C., Sinha, Aditi, Dart, Allison, Eddy, Allison A., Gipson, Debbie S., Bockenhauer, Detlef, Yap, Hui-Kim, Groothoff, Jaap, Zappitelli, Michael, J.A.Webb, Nicholas, Alexander, Stephen I., Furth, Susan, Samuel, Susan, Blydt-Hansen, Tom D., Dionne, Janis, Michael, Mini, Wenderfer, Scott E., Winkelmayer, Wolfgang C., McTaggart, Steven, Walker, Amanda, Zimmerman, Cortney T., Ralph, Angelique F., Ju, Angela, James, Laura J., and Hanson, Camilla S.

Published
2023
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10. Two SARS-CoV-2 Genome Sequences of Isolates from Rural U.S. Patients Harboring the D614G Mutation, Obtained Using Nanopore Sequencing.

Author

Jenjaroenpun, Piroon, Wanchai, Visanu, Ono-Moore, Kikumi D, Laudadio, Jennifer, James, Laura P, Adams, Sean H, Prior, Fred, Nookaew, Intawat, Ussery, David W, and Wongsurawat, Thidathip

Subjects
Genetics, Human Genome, Prevention, Lung, Biotechnology, Nanotechnology, Pneumonia & Influenza, Bioengineering, Pneumonia, Vaccine Related
Abstract

Two coding-complete sequences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were obtained from samples from two patients in Arkansas, in the southeastern corner of the United States. The viral genome was obtained using the ARTIC Network protocol and Oxford Nanopore Technologies sequencing.

Published
2020

11. Correction to: The association between socioeconomic disadvantage and parent-rated health in children and adolescents with chronic kidney disease—the Kids with CKD (KCAD) study

Author

Didsbury, Madeleine, van Zwieten, Anita, Chen, Kerry, James, Laura J., Francis, Anna, Kim, Siah, McTaggart, Steven, Walker, Amanda, Mackie, Fiona, Kara, Tonya, Prestidge, Chanel, Teixeira-Pinto, Armando, Barton, Belinda, Lorenzo, Jennifer, Lah, Suncica, Howard, Kirsten, Nassar, Natasha, Au, Eric, Tong, Allison, Craig, Jonathan C., and Wong, Germaine

Published
2022
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12. Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population.

Author

Thompson, Elizabeth J., Jeong, Angela, Helfer, Victória E., Shakhnovich, Valentina, Edginton, Andrea, Balevic, Stephen J., James, Laura P., Collier, David N., Anand, Ravinder, Gonzalez, Daniel, Benjamin, Daniel K., Kennel, Phyllis, Alderman, Cheryl, Sund, Zoe, Opel, Kylie, Beci, Rose, Hornik, Chi D., Kearns, Gregory L., Paul, Ian M., and Sullivan, Janice

Subjects
CHILDHOOD obesity, BODY weight, PROTON pump inhibitors, CHILD patients, BODY size, OVERWEIGHT children
Abstract

Pantoprazole is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease, a condition that disproportionately affects children with obesity. Appropriately dosing pantoprazole in children with obesity requires understanding the body size metric that best guides dosing, but pharmacokinetic (PK) trials using traditional techniques are limited by the need for larger sample sizes and frequent blood sampling. Physiologically‐based PK (PBPK) models are an attractive alternative that can account for physiologic‐, genetic‐, and drug‐specific changes without the need for extensive clinical trial data. In this study, we explored the effect of obesity on pantoprazole PK and evaluated label‐suggested dosing in this population. An adult PBPK model for pantoprazole was developed using data from the literature and accounting for genetic variation in CYP2C19. The adult PBPK model was scaled to children without obesity using age‐associated changes in anatomical and physiological parameters. Lastly, the pediatric PBPK model was expanded to children with obesity. Three pantoprazole dosing strategies were evaluated: 1 mg/kg total body weight, 1.2 mg/kg lean body weight, and US Food and Drug Administration‐recommended weight‐tiered dosing. Simulated concentration–time profiles from our model were compared with data from a prospective cohort study (PAN01; NCT02186652). Weight‐tiered dosing resulted in the most (>90%) children with pantoprazole exposures in the reference range, regardless of obesity status or CYP2C19 phenotype, confirming results from previously published population PK models. PBPK models may allow for the efficient study of physiologic and developmental effects of obesity on PK in special populations where clinical trial data may be limited. [ABSTRACT FROM AUTHOR]

Published
2024
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16. The Effect of Structured Divergent Prompts on Knowledge Construction

Author

Howell, Ginger S., Akpanudo, Usenime, Chen, Mengyi, Sutherlin, Autumn L., and James, Laura E.

Abstract

Discussion forums are a widely used activity in online courses. However, knowledge construction within online discussion rarely reaches higher levels. Therefore, it is important to understand which aspects of online discussion encourage learning and increase knowledge construction. This paper investigates the effect three Structured Divergent prompts (playground prompts, brainstorm prompts, and focal prompts) have on knowledge construction as compared to Convergent prompts. Participants (N = 58) were required to post in an online discussion thread during a graduate education course at a private university. The Interaction Analysis Model was used to determine the levels of knowledge construction demonstrated within students' posts. The posts were given a score using the following codes: 0-no post/no understandable post; 1-sharing information, 2-disagreeing; 3-negotiation of meaning; 4-testing co-construction; 5-agreement of the constructed meaning. The analysis revealed that two of the three Structured Divergent prompts (focal and brainstorm) yielded significantly higher levels of knowledge construction as compared to Convergent prompts.

Published
2014

22. Hands-Free Analytical Urine Testing Technology Validated for Drug-Facilitated Crime Investigations

Author

Avram, Marina, primary, Bodinger, Carter A., additional, Clark, Madeline A., additional, Stuckey, Daniel G., additional, Mathews, Samuel E., additional, Stogsdill, Susan N., additional, Barna, Elyse C., additional, Williams, David K., additional, McGill, Mitchell, additional, Fantegrossi, William E., additional, Liebelt, Erica L., additional, James, Laura P., additional, Endres, Gregory W., additional, and Moran, Jeffery H., additional

Published
2023
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25. Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures

Author

Benjamin, Daniel K., Jr, Berezny, Katherine Y., Wolkowiez, P. Michael Cohen, Laughon, Matthew M., Paul, Ian M., Smith, Michael J., van den Anker, John, Wade, Kelly, Siegel, David, Taylor-Zapata, Perdita, Zajicek, Anne, Ren, Zhaoxia, Tsilou, Ekaterini, Pagan, Alice, Anand, Ravinder, Clemons, Traci, Simone, Gina, Howard, Lee, Weigel, Jaylene, Darden Saad, Nancy, Shakhnovich, Valentina, Smith, P. Brian, Guptill, Jeffrey T., James, Laura P., Collier, David N., Wu, Huali, Livingston, Chad E., Zhao, Jian, and Kearns, Gregory L.

Published
2018
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26. The association between socioeconomic disadvantage and parent-rated health in children and adolescents with chronic kidney disease—the Kids with CKD (KCAD) study

Author

Didsbury, Madeleine, van Zwieten, Anita, Chen, Kerry, James, Laura J., Francis, Anna, Kim, Siah, McTaggart, Steven, Walker, Amanda, Mackie, Fiona, Kara, Tonya, Prestidge, Chanel, Teixeira-Pinto, Armando, Barton, Belinda, Lorenzo, Jennifer, Lah, Suncica, Howard, Kirsten, Nassar, Natasha, Au, Eric, Tong, Allison, Craig, Jonathan C., and Wong, Germaine

Published
2019
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30. Multiple microRNAs function as self-protective modules in acetaminophen-induced hepatotoxicity in humans

Author

Yu, Dianke, Wu, Leihong, Gill, Pritmohinder, Tolleson, William H., Chen, Si, Sun, Jinchun, Knox, Bridgett, Jin, Yaqiong, Xiao, Wenming, Hong, Huixiao, Wang, Yong, Ren, Zhen, Guo, Lei, Mei, Nan, Guo, Yongli, Yang, Xi, Shi, Leming, Chen, Yinting, Zeng, Linjuan, Dreval, Kostiantyn, Tryndyak, Volodymyr, Pogribny, Igor, Fang, Hong, Shi, Tieliu, McCullough, Sandra, Bhattacharyya, Sudeepa, Schnackenberg, Laura, Mattes, William, Beger, Richard D., James, Laura, Tong, Weida, and Ning, Baitang

Published
2018
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36. Learning and Innovation in the Knowledge-Based Economy: Beyond Clusters and Qualifications

Author

James, Laura, Guile, David, and Unwin, Lorna

Abstract

For over a decade policy-makers have claimed that advanced industrial societies should develop a knowledge-based economy (KBE) in response to economic globalisation and the transfer of manufacturing jobs to lower cost countries. In the UK, this vision shaped New Labour's policies for vocational education and training (VET), higher education and skills, and it continues to be influential. Learning for the KBE, according to policy-makers' claims, requires individuals to acquire measurable knowledge or skills in the form of qualifications through formal education and training, which will allegedly improve national economic competitiveness and productivity. This paper argues that quite different conceptualisations of learning for the KBE can be drawn from the fields of economic geography and regional studies; in particular, the "cluster" literature, which analyses the processes which underpin innovation and learning in regional agglomerations of economic activity. The paper argues that the cluster literature can and should be used to open up a debate about the nature, scale and location of the learning processes that support the KBE; the implications of which have not yet been fully appreciated in the fields of VET and skills policy. Moreover, when these insights are combined with those from social theories of learning, a more holistic understanding of how innovation occurs emerges. The paper concludes with some recommendations for the Coalition Government as it develops policies to rebalance and grow the UK economy, and suggests that these recommendations may also be relevant for other countries facing similar challenges.

Published
2013
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37. Forensic investigation of K2, Spice, and “bath salt” commercial preparations: A three-year study of new designer drug products containing synthetic cannabinoid, stimulant, and hallucinogenic compounds

Author

Seely, Kathryn A., Patton, Amy L., Moran, Cindy L., Womack, Mary L., Prather, Paul L., Fantegrossi, William E., Radominska-Pandya, Anna, Endres, Gregory W., Channell, Kermit B., Smith, Nathaniel H., McCain, Keith R., James, Laura P., and Moran, Jeffery H.

Published
2013
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38. Solithromycin in Children and Adolescents with Community-acquired Bacterial Pneumonia

Author

Lang, Jason E., Hornik, Christoph P., Elliott, Carrie, Silverstein, Adam, Hornik, Chi, Al-Uzri, Amira, Bosheva, Miroslava, Bradley, John S., Borja-Tabora, Charissa Fay Corazon, John, David Di, Echevarria, Ana Mendez, Ericson, Jessica E., Friedel, David, Gonczi, Ferenc, Isidro, Marie Grace Dawn, James, Laura P., Kalocsai, Krisztina, Koutroulis, Ioannis, Laki, Istvan, Ong-Lim, Anna Lisa T., Nad, Marta, Simon, Gabor, Syed, Salma, Szabo, Eva, Benjamin, Daniel K., and Cohen-Wolkowiez, Michael

Subjects
Community-Acquired Infections, Adolescent, Pneumonia, Bacterial, Humans, Macrolides, Triazoles, Child, Article, Anti-Bacterial Agents
Abstract

BACKGROUND: Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP. METHODS: This phase 2/3, randomized, open-label, active-control, multi-center study randomly assigned solithromycin (capsules, suspension or intravenous) or an appropriate comparator antibiotic in a 3:1 ratio (planned n=400) to children 2 months to 17 years of age with CABP. Primary safety endpoints included treatment-emergent adverse events (TEAE) and AE-related drug discontinuations. Secondary effectiveness endpoints included clinical improvement following treatment without additional antimicrobial therapy. RESULTS: Unrelated to safety, the sponsor stopped the trial prior to completion. Before discontinuation, 97 participants were randomly assigned to solithromycin (n=73) or comparator (n=24). There were 24 participants (34%, 95% CI, 23-47%) with a TEAE in the solithromycin group and 7 (29%, 95% CI, 13-51%) in the comparator group. Infusion site pain and elevated liver enzymes were the most common related AEs with solithromycin. Study drug was discontinued due to AEs in 3 subjects (4.3%) in the solithromycin group and 1 (4.2%) in the comparator group. Forty participants (65%, 95% CI, 51-76%) in the solithromycin group achieved clinical improvement on the last day of treatment versus 17 (81%, 95% CI, 58-95%) in the comparator group. The proportion achieving clinical cure was 60% (95% CI, 47-72%) and 68% (95% CI, 43-87%) for the solithromycin and comparator groups, respectively. CONCLUSION: Intravenous and oral solithromycin were generally well-tolerated and associated with clinical improvement in the majority of participants treated for CABP.

Published
2022

44. Exogenous phosphatidic acid reduces acetaminophen-induced liver injury in mice by activating hepatic interleukin-6 signaling through inter-organ crosstalk

Author

Clemens, Melissa M., primary, Kennon-McGill, Stefanie, additional, Vazquez, Joel H., additional, Stephens, Owen W., additional, Peterson, Erich A., additional, Johann, Donald J., additional, Allard, Felicia D., additional, Yee, Eric U., additional, McCullough, Sandra S., additional, James, Laura P., additional, Finck, Brian N., additional, and McGill, Mitchell R., additional

Published
2021
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46. The Spice of Death

Author

Steele, Ryan W., primary, Moran, Jeffery H., additional, Patton, Amy L., additional, Kokes, Charles P., additional, James, Laura P., additional, Storm, Elizabeth A., additional, and Schexnayder, Stephen M., additional

Published
2021
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47. Short‐Term Safety of Repeated Acetaminophen Use in Patients With Compensated Cirrhosis

Author

McGill, Mitchell R., primary, James, Laura P., additional, McCullough, Sandra S., additional, Moran, Jeffery H., additional, Mathews, Samuel E., additional, Peterson, Eric C., additional, Fleming, Davis P., additional, Tripod, Morgan E., additional, Vazquez, Joel H., additional, Kennon‐McGill, Stefanie, additional, Spencer, Horace J., additional, and Dranoff, Jonathan A., additional

Published
2021
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