Clinical trial NCT01388439: Pharmacokinetics of Oseltamivir in Newborns and Infants
Official title: Pharmacokinetics of Oseltamivir in Newborns and Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity of Fetus
Keywords: oseltamivir
influenza
neonate
premature
pharmacokinetics
Lead sponsor: St. Louis Children's Hospital
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Washington University School of Medicine
First posted: 2011-07-06
Enrollment: 19
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One infant in the Neonatal Intensive Care Unit (NICU) at St. Louis Children's Hospital experienced respiratory decompensation and tested positive for influenza virus type A by fluorsescent antibody stain performed on a nasopharyngeal swab. This infant received treatment doses of oseltamivir. Subsequently, 27 other infants received oseltamivir prophylaxis for exposure to influenza virus type A. Exposed infants were those who shared a primary medical team, nursing care, respiratory therapist, physical therapist, or occupational therapist with the influenza A positive infant. Prophylaxis was deemed necessary by the attending neonatologist after consultation with the Infectious Diseases Division of the Department of Pediatrics at the Washington University School of Medicine.

Brief summary: Oseltamivir dosing in infants \< 3 months of age is based on a single pharmacokinetic study in 20 infants from a single center. This dataset is limited by a lack of robustness, because only 1 sample was collected from each participant. The investigators obtained two blood samples each from infants receiving oseltamivir after obtaining informed consent from the infant's parents. The investigators propose to analyze the blood samples to determine the amount of oseltamivir in the infant's blood. Measurement of these values will increase the understanding of the absorption and elimination of oseltamivir in preterm and term infants, and improve our ability to provide the correct doses to this high risk population.


Eligibility criteria: Inclusion Criteria:

* All neonates and infants in the NICU at St. Louis Children's Hospital who received oseltamivir for treatment of or exposure to influenza virus type A were considered eligible for this study.

Primary outcomes:
measure: Oseltamivir pharmacokinetics in neonates and infants
timeFrame: Two sample points, one 0-3 hours (baseline) and one 3-24 hours post dose
Secondary outcomes:
measure: Oseltamivir target level attainment
timeFrame: Two sample points, one 0-3 hours (baseline) and one 3-24 hours post dose
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Louis Children's Hosptial
state: Missouri
Study officials:
References:
citation: Acosta EP, Jester P, Gal P, Wimmer J, Wade J, Whitley RJ, Kimberlin DW; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Oseltamivir dosing for influenza infection in premature neonates. J Infect Dis. 2010 Aug 15;202(4):563-6. doi: 10.1086/654930.
citation: Fiore AE, Fry A, Shay D, Gubareva L, Bresee JS, Uyeki TM; Centers for Disease Control and Prevention (CDC). Antiviral agents for the treatment and chemoprophylaxis of influenza --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 21;60(1):1-24.