An open label multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in childre

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

• Males or females 1 to 12 years of age; females must be pre-menarchal
• Subject is a candidate for seasonal prophylaxis in the opinion of the Principal
investigator
• Negative rapid diagnostic test for influenza at baseline
• Parent/guardian willing and able to comply with study requirements and give consent
• Subject able to comply with study requirements and willing to give assent, as
appropriate
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

• Symptoms suggestive of influenza-like illness, including but not limited to, fever,
cough, or nasal congestion
• Positive rapid diagnostic test for influenza
• Creatinine clearance < 30 ml/min/1.73M2
• Females of child-bearing potential
• Uncontrolled renal, vascular, neurologic, metabolic, or pulmonary disease or known chronic renal failure, hepatitis or cirrhosis. Uncontrolled is defined as disease requiring change of therapy or hospitalization within 4 weeks preceding the first dose of study medication. Change of therapy is defined as dose increase or change of medication.
• Allergy to the test medication
• Hereditary fructose intolerance (for subjects who will be taking the liquid formulation)
• Malignancy at the time of randomization excluding adequately treated skin carcinoma (basal or squamous cell)
• Participation in a clinical trial with an investigational drug in the 4 weeks prior to
randomization. Patients enrolled in this study can not be enrolled in another study
for either research, diagnostic or treatment purposes.
• Antiviral treatment (example: amantadine, rimantadine, zanamavir, oseltamivir
and ribavirin) for influenza in the 2 weeks prior to randomization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •to evaluate the safety of 6 weeks of seasonal prophylaxis of influenza in children<br>•to evaluate the effect of oseltamivir in preventing laboratory confirmed clinical influenza in children<br>;Secondary Objective: ;Primary end point(s): The efficacy end points in the study are:<br>1. Proportion of subjects with laboratory confirmed clinical influenza.<br>2. Proportion of subjects with laboratory confirmed influenza.<br>3. Proportion of subjects with asymptomatic influenza.<br>4. Proportion of subjects with an influenza-like illness not caused by influenza virus<br>infection.<br><br><br>

Secondary Outcome Measures

Name	Time	Method

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