Efficacy Study of Early Versus Late Oseltamivir Administration for Treating and Preventing Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the
      duration and severity of influenza symptoms, and duration of viral shedding, in influenza
      patients receiving oseltamivir early and late relative to placebo.

      There are two main hypotheses in this study:

        1. The duration of influenza symptoms, mean severity score, and duration of viral shedding
           are reduced in patients who initiate oseltamivir treatment late (48 to 119 hours)
           compared to those receiving no antiviral therapy.

        2. Prior influenza vaccination (same season) reduces the duration of influenza symptoms and
           mean symptom severity in patients receiving oseltamivir after adjusting for age and
           timing of antiviral therapy (early versus late).

      There are two secondary hypotheses:

        1. The duration of influenza symptoms, mean severity score, and duration of viral shedding
           are reduced in patients with influenza who initiate oseltamivir treatment early (< 48
           hours) versus late (48 to 119 hours).

        2. The incidence of secondary complications is lower in patients initiating oseltamivir
           therapy late relative to those receiving no antiviral therapy.
    

Detailed description: 
      In the past decade influenza has become increasingly recognized as a serious disease and
      pandemic threat. Elderly persons, young children, and individuals with chronic medical
      conditions have the greatest risk for complications or death from influenza infection.
      Neuraminidase inhibitors are currently licensed for the treatment and prevention of influenza
      if started early in the course of illness, but little is known regarding the effects of
      oseltamivir (one neuraminidase inhibitor) on illness severity when initiated later in the
      course of illness. Greater knowledge of the treatment effects is urgently needed for optimal
      management of seasonal influenza, and to maximize use of a limited stockpile of antiviral
      drugs in the event of an influenza pandemic.
    

Intervention name(s): Oseltamivir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses); Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: randomized; blinded; controlled; efficacy