Pharmacokinetics of Oseltamivir in Newborns and Infants

St. Louis Children's Hospital

Status: Completed

Conditions: Prematurity of Fetus

Treatments: Drug: Oseltamivir

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01388439

TAM 027

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

19 participants in 1 patient group

Oseltamivir exposure

Description:

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 fluorescent 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.

Treatment:

Drug: Oseltamivir