Browsing by Author "Ericson, Jessica E"
Now showing 1 - 2 of 2
- Results Per Page
- Sort Options
Item Open Access Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease.(Early human development, 2022-07) Ericson, Jessica E; Benjamin, Daniel K; Boakye-Agyeman, Felix; Balevic, Stephen J; Cotten, C Michael; Adler-Shohet, Felice; Laughon, Matthew; Poindexter, Brenda; Harper, Barrie; Payne, Elizabeth H; Kaneshige, Kim; Smith, P Brian; Best Pharmaceuticals for Children Act - Pediatric Trials NetworkBackground
Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991.Aims
Determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir; examine the association between acyclovir dose and exposure with adverse events (AEs).Study design
We obtained demographic information and acyclovir dosing via medical records. Acyclovir exposure was calculated using an established pharmacokinetic model.Subjects
Infants <120 days of age with neonatal HSV discharged from four academic children's hospitals.Outcome measures
We identified clinical and laboratory adverse events (AEs).Results and conclusions
We identified 49 infants with neonatal HSV treated with acyclovir; 42 infants had complete 21-day dosing information. Median mean daily dose was 59 mg/kg/day. Clinical AEs were common among all gestational and postnatal age groups. Rash was the most common clinical AE (37 %). Mild laboratory AEs occurred in 2-37 % of infants. The median maximum doses (mg/kg/day) were higher among infants with hypokalemia, elevated blood urea nitrogen, and thrombocytosis. For all other laboratory AEs, the median maximum doses for infants without events were higher or equal to the median maximum dose of infants with the AE. The odds of experiencing any clinical or laboratory AE did not differ by predicted acyclovir exposure for either area under the curve (AUC) or maximum concentration (Cmax) (odds ratio [OR] = 1.00 [0.98, 1.03] and OR = 1.01 [0.93, 1.12], respectively). Although AEs were common with high-dose acyclovir exposure, severe AEs were rare. Acyclovir exposure was not associated with AEs.Item Open Access Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.(The Pediatric infectious disease journal, 2022-07) 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; Di John, David; Mendez Echevarria, Ana; 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; Cohen-Wolkowiez, Michael; SOLI-PEDS ProgramBackground
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, multicenter 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 (AEs) 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 treatment-emergent AE 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.Conclusions
Intravenous and oral solithromycin were generally well-tolerated and associated with clinical improvement in the majority of participants treated for CABP.