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4. Antibiotic treatment duration for bloodstream infections in critically ill children—A survey of pediatric infectious diseases and critical care clinicians for clinical equipoise

Author

Pong, Sandra, primary, Fowler, Robert A., additional, Murthy, Srinivas, additional, Pernica, Jeffrey M., additional, Gilfoyle, Elaine, additional, Fontela, Patricia, additional, Mitsakakis, Nicholas, additional, Bowen, Asha C., additional, Seto, Winnie, additional, Science, Michelle, additional, Hutchison, James S., additional, Jouvet, Philippe, additional, Rishu, Asgar, additional, and Daneman, Nick, additional

Published
2022
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18. Nevirapine Pharmacokinetics and Safety in Neonates Receiving Combination Antiretroviral Therapy for Prevention of Vertical HIV Transmission

Author

Lau, Elaine, primary, Brophy, Jason, additional, Samson, Lindy, additional, Kakkar, Fatima, additional, Campbell, Douglas M., additional, Yudin, Mark H., additional, Murphy, Kellie, additional, Seto, Winnie, additional, Colantonio, David, additional, Read, Stanley E., additional, and Bitnun, Ari, additional

Published
2017
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24. 12-Hour versus24-Hour Creatinine Clearance in Critically Ill Pediatric Patients

Author

PONG, SANDRA, SETO, WINNIE, ABDOLELL, MOHAMED, TROPE, ANGELA, WONG, KAREN, HERRIDGE, JOANN, HARVEY, ELIZABETH, and KAVANAGH, BRIAN P.

Abstract

Measurement of renal function is important to optimize drug dosing in critically ill pediatric patients and to prevent dose-related toxicities caused by medications that are eliminated or metabolized by the kidney. In clinical practice, the 24-h creatinine clearance (CrCl) is used as a surrogate marker of renal function. However, a 24-h urine collection period delays the availability of the result and increases the potential for collection errors. This prospective, observational study was performed to determine whether a 12-h CrCl is comparable to the traditional 24-h CrCl and to assess whether CrCl could be reliably predicted by the Schwartz equation, which mathematically estimates a child's GFR. A 24-h urine sample was collected in two 12-h aliquots from 60 catheterized critically ill children (age 2 d to 18 y). CrCl and Schwartz glomerular filtration rate (GFR) estimates were determined for each 12- and 24-h period. Agreement between 12- and 24-h CrCl and between CrCl and Schwartz GFR estimates was assessed using intraclass correlation coefficients (ICCs). An ICC ≥0.8 was considered to indicate excellent agreement. The ICC between the first 12-h CrCl and 24-h CrCl was 0.9605. The ICC between the second 12-h CrCl and 24-h CrCl was 0.9602. The ICC between the 24-h CrCl and Schwartz GFR was only 0.7046. All comparisons of 12- and 24-h CrCl indicated excellent agreement. In summary, the Schwartz equation was not a reliable estimate of renal function in critically ill children, and a 12-h CrCl is just as accurate as the standard 24-h CrCl to assess renal function and guide drug dosing.

Published
2005
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25. Nevirapine Pharmacokinetics and Safety in Neonates Receiving Combination Antiretroviral Therapy for Prevention of Vertical HIV Transmission.

Author

Lau E, Brophy J, Samson L, Kakkar F, Campbell DM, Yudin MH, Murphy K, Seto W, Colantonio D, Read SE, and Bitnun A

Subjects
Adult, Anti-HIV Agents administration & dosage, Antiretroviral Therapy, Highly Active adverse effects, Chemoprevention adverse effects, Chemoprevention methods, Female, Humans, Infant, Newborn, Male, Nevirapine administration & dosage, Prospective Studies, Retrospective Studies, Young Adult, Anti-HIV Agents adverse effects, Anti-HIV Agents pharmacokinetics, Antiretroviral Therapy, Highly Active methods, HIV Infections prevention & control, Infectious Disease Transmission, Vertical prevention & control, Nevirapine adverse effects, Nevirapine pharmacokinetics
Abstract

Background: Nevirapine (NVP)-based combination antiretroviral therapy is routinely prescribed to infants deemed at high risk of vertical HIV infection in our centers. We evaluated NVP pharmacokinetics and safety of this regimen., Methods: Neonates were recruited prospectively between September 2012 and April 2015 or enrolled retrospectively if treated similarly before prospective study initiation. NVP was dosed at 150 mg/m daily for 14 days, then twice daily for 14 days. NVP levels were drawn at weeks 1, 2, and 4 [target trough (NVP-T): 3-8 mg/L]., Results: Thirty-three neonates were included (23 prospectively). Median gestational age (GA) and birth weight were 38 weeks (32-41 weeks) and 2.9 kg (1.5-4.2 kg), respectively. Median NVP-Ts were 8.2 mg/L (1.6-25.1 mg/L), 3.5 mg/L (1.6-6.8 mg/L), and 4.3 mg/L (0.1-19.9 mg/L) at weeks 1, 2, and 4, respectively. The proportions with therapeutic NVP-T were 42%, 61%, and 73% at these same timepoints. Median apparent oral clearance (CL/F) increased from 0.05 L·kg·h (0.01-0.50 L·kg·h) at week 2 to 0.18 L·kg·h (0.01-0.78 L·kg·h) at week 4. Increased drug exposure [area under the curve (AUCτ)] correlated with younger GA (r = 0.459, P = 0.032) and lower birth weight (r = 0.542, P = 0.009). The most common adverse events potentially attributable to combination antiretroviral therapy were transient asymptomatic hyperlactatemia (26%), anemia (24.7%), and neutropenia (22.1%)., Conclusions: Treatment dose NVP was generally well-tolerated and associated with normalization of trough levels over time in most cases without dose adjustment. Lower empiric dosing is recommended for infants <34 weeks of GA. Routine therapeutic drug monitoring may not be required for infants ≥34 weeks of GA.

Published
2017
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26. Drug formulations that require less than 0.1 mL of stock solution to prepare doses for infants and children.

Author

Uppal N, Yasseen B, Seto W, and Parshuram CS

Subjects
Administration, Oral, Canada, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Infusions, Intravenous, Intensive Care Units, Pediatric, Male, Models, Theoretical, Chemistry, Pharmaceutical standards, Medication Errors prevention & control
Abstract

Intravenous doses of medications require formulations that permit accurate preparation and administration. Current equipment does not permit accurate measurement of volumes less than 0.1 mL. In a study of four hypothetical standard pediatric patients, we found that 28 common medications required less than 0.1 mL of available formulation to prepare the dose. In a clinical study of actual use in a pediatric intensive care unit (ICU), 5245 (7.4%) of 71 218 intravenous doses required preparation from less than 0.1 mL of stock solution. For 28.5% of the 1531 ICU admissions, at least one dose was prepared from a volume of less than 0.1 mL. Our findings identify a substantial source of dosing error. Correction will require revision of preparation methods, regulatory requirements and manufacturing practices.

Published
2011
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