Trial reportAntimicrobial agents and chemotherapy2012
Oseltamivir pharmacokinetics and clinical experience in neonates and infants during an outbreak of H1N1 influenza A virus infection in a neonatal intensive care unit.
Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 27 citations in OpenAlex.
- Dosing of Ceftriaxone and Metronidazole for Children With Severe Acute Malnutrition.Clinical pharmacology and therapeutics · 2018Trial
- Population pharmacokinetics of oseltamivir in non-pregnant and pregnant women.British journal of clinical pharmacology · 2015Trial
- Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations.The AAPS journal · 2020Article
- Pharmacokinetics of ticarcillin-clavulanate in premature infants.British journal of clinical pharmacology · 2019Article
- Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.Clinical pharmacokinetics · 2019Review
- Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.Journal of clinical pharmacology · 2018Review
- Scaling clearance in paediatric pharmacokinetics: All models are wrong, which are useful?British journal of clinical pharmacology · 2017Article
- The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans.PloS one · 2017Article
- Population pharmacokinetics of oseltamivir and oseltamivir carboxylate in obese and non-obese volunteers.British journal of clinical pharmacology · 2016Article
- Advances in pediatric pharmacology, therapeutics, and toxicology.Advances in pediatrics · 2014Review
- Pharmacokinetic studies in infants using minimal-risk study designs.Current clinical pharmacology · 2014Review
- Oseltamivir pharmacokinetics, dosing, and resistance among children aged <2 years with influenza.The Journal of infectious diseases · 2013Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
Detailed oseltamivir pharmacokinetics have yet to be reported in neonates and infants; this group is at high risk of serious influenza-associated complications. Extrapolation of doses from older patients is complicated by rapid organ and drug-metabolizing enzyme maturation. A pharmacokinetic study has been conducted during an influenza A(H1N1) outbreak in a neonatal intensive care unit. Each included patient provided 4 samples for oseltamivir and 4 samples for its active metabolite oseltamivir carboxylate. A population pharmacokinetic model was developed with NONMEM. Allometric weight scaling and maturation functions were added a priori to scale for size and age based on literature values. Nine neonates and infants were recruited. A physiologically parameterized pharmacokinetic model predicted typical day 1 area under the curve (AUC(0-12)) values of 1,966 and 2,484 μg · h/liter for neonates and infants of ≤ 37 weeks of postmenstrual age (PMA) and >37 weeks of PMA treated with 1 mg/kg of body weight and 2 mg/kg, respectively. The corresponding steady-state AUC(0-12) values were 3,670 and 4,559 μg · h/liter. Premature neonates treated with 1 mg/kg and term babies treated with 2 mg/kg should have average oseltamivir carboxylate concentrations in a range similar to that for adults treated with 75 mg, corresponding to >200-fold above the half-maximal inhibitory concentration (IC(50)) value for influenza A(H1N1) from the start of therapy.
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