An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection. - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 85

Inclusion Criteria

1. Post natal* age: Cohort I: 3 to < 12 months, Cohort II: 1 to <3 months, Cohort III: 0 to 30 days. * Post natal age = date of birth to date of enrolment; 2. Confirmed laboratory diagnosis of influenza by PCR or rapid influenza diagnostic test within 96 hours prior to first dose; 3. Duration of influenza symptoms ≤ 96 hours prior to first dose.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Post conceptual* age less than 36 weeks. *Post conceptual age = Gestational age + post natal age Gestational age = date of conception to date of birth (date of conception is usually two weeks after last menstrual period); 2.Participation in an investigational drug or device study within 30 days prior to screening; 3.Requiring inotropic support or vasopressors at the time of enrollment; 4.Concurrent gastrointenstinal conditions that preclude enteric absorption of the drug (eg. protracted vomiting, malabsorption, history of necrotizing enterocolitis with short gut); 5. Bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at the time of enrollment; 6.Subjects with diminished ventilatory reserve at risk for hypercapnia (eg. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, history of surgery for diaphragmatic hernia); 7.Left to right shunt requiring therapy; 8.Renal failure including renal anomalies likely to be associated with renal dysfunction (e.g. clinical conditions of renal dysplasia, polycystic renal disease, renal agenesis); 9.Clinical evidence for hepatic decompensation (liver disease with coagulopathy, encephalopathy); 10.Cerebral palsy with microcephaly, feeding difficulties or seizures; 11.Infants symptomatic due to inborn errors of metabolism (e.g. glycogen storage disorders); 12.Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinemia, immunosuppressive therapy); 13.Have evidence of active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease unrelated to influenza at baseline; 14.Allergy to test medication; 15. Subjects with hereditary fructose intolerance; Et al...

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To define the pharmacokinetics of oseltamivir and oseltamivir carboxylate in children with confirmed influenza up to one year of age.;Secondary Objective: -To describe the frequency of all adverse events among treated children; -To assess the clearance of virus and viral RNA; -To determine the potential for the development of resistance to oseltamivir; -To explore other pharmacodynamic parameters (e.g. resolution of fever).;Primary end point(s): The primary variables are the steady-state pharmacokinetic parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate.

Secondary Outcome Measures

Name	Time	Method

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