Summary

for people ages 18-64 (full criteria)
at San Diego, California and other locations
study started

Description

Summary

People who are infected with the influenza virus may develop respiratory illnesses, such as pneumonia, or other life-threatening complications. Currently, there are four antiviral medications that are used to treat influenza. This study will examine one of these medications, oseltamivir, to examine how it affects the shedding of influenza virus in infected people.

Official Title

A Randomized Double-Blind Study Comparing Oseltamivir Versus Placebo for the Treatment of Influenza in Low Risk Adults

Details

Seasonal influenza is responsible for excess hospitalizations and, despite effective antivirals, causes significant morbidity and mortality (about 24,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S.) but in contrast to seasonal flu, nearly 90% of the deaths with the 2009 H1N1 occurred among people younger than 65 years of age. Although there are four currently licensed anti-influenza medications (amantadine and rimantadine, oseltamivir, and zanamivir), previous studies have not demonstrated conclusively to what extent these medications affect influenza viral shedding. This study will evaluate whether oseltamivir modifies the viral shedding during the treatment of uncomplicated influenza in an adult population and also assess methods to detect viral replication in the upper respiratory tract.

Subjects who present with an influenza-like illness without any risk factors for severe disease will be screened for the study. Those with a confirmatory test for influenza (rapid antigen or polymerase chain reaction [PCR]) will be randomized in a 1:1 manner to receive a blinded study treatment consisting of either the oseltamivir or placebo for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, and 28 will be used for both safety and efficacy analysis.

Keywords

Influenza, Human H1N1 Complications PCR Seasonal Influenza Viral Shedding Oseltamivir

Eligibility

You can join if…

Open to people ages 18-64

  • Written informed consent prior to initiation of any study procedures
  • History of an influenza-like illness defined as:

1) One or more respiratory symptom (cough, sore throat, or nasal symptoms)

  • Onset of illness no more than 48 hours before screening, defined as when the participant experienced at least one respiratory symptom
  • Willing to have samples stored
  • Positive test for influenza (either rapid antigen or polymerase chain reaction [PCR]);randomization may proceed in cases of discrepant results (one positive and one negative)

You CAN'T join if...

  • Hospitalization at the time of screening
  • Presence of a medical condition(s) that has been associated with increased risk of complications from influenza
  • Age 65 years of age or older
  • Asthma
  • Neurological and neuro-developmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle, such as cerebral palsy,epilepsy [seizure disorders], stroke, moderate to severe developmental delay,muscular dystrophy, or spinal cord injury)
  • Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] or cystic fibrosis)
  • Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
  • Blood disorders
  • Endocrine disorders (such as diabetes mellitus)
  • Kidney disorders
  • Liver disorders
  • . Metabolic disorders (such as inherited metabolic disorders or mitochondrial disorders)
  • . Weakened immune system due to disease or medication (such as people with HIV/AIDS or cancer, or use of chronic steroids or other medications causing immune suppression)
  • . Pregnant or 4 weeks postpartum
  • . Body mass index (BMI) greater than or equal to 40
  • Breastfeeding
  • Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication
  • Received more than one dose of any antiviral influenza medication since onset of influenza symptoms
  • Known end stage kidney dysfunction (e.g., creatinine clearance less than 30 mL/min)
  • Known hypersensitivity to oseltamivir, peramivir, or zanamivir
  • Received live attenuated influenza virus vaccine within 3 weeks prior to study entry
  • Use of any investigational drug within 30 days or 5 half-lives (whichever is longer)prior to study entry
  • Participation in other research protocols that require more than 100mL of blood to be drawn in a 4-week period that overlaps with this study.

Locations

  • University of California, San Diego
    San Diego California 92103 United States
  • University of Southern California
    Los Angeles California 92103 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT01314911
Study Type
Interventional
Last Updated