Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

Completed · Not applicable · Has a placebo group

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID

NCT01314911

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

716

Starts

2011-04-01

Expected to finish

2017-11-18

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent prior to initiation of any study procedures
• History of an influenza-like illness defined as:
• 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 could proceed in cases of discrepant results (one positive and one negative)

You may not qualify if…

• Hospitalization at the time of screening
• Presence of a medical condition(s) that had been associated with increased risk of complications from influenza
• Aged 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 was longer) prior to study entry
• Participated in other research protocols that required more than 100mL of blood to be drawn in a 4-week period that overlapped with this study.

Where it is running

• WCCT Global, LLC — Costa Mesa, California, United States
• Paragon Rx Clinical — Garden Grove, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Westlake Medical Research — Thousand Oaks, California, United States
• Advanced Rx Clinical Research Group — Westminster, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Best Quality Research, Inc. — Hialeah, Florida, United States
• Medical Consulting Center — Miami, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• DMI Research, Inc. — Pinellas Park, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Research Integrity, LLC — Owensboro, Kentucky, United States
• Horizon Research Group of Opelousas, LLC — Eunice, Louisiana, United States
• Michael Seep, MD; Centex Studies — Lake Charles, Louisiana, United States
• National Institutes of Health, Laboratory of Immunoregulation — Bethesda, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Skyline Medical Center — Elkhorn, Nebraska, United States
• Prairie Fields Family Medicine — Fremont, Nebraska, United States
• Southwest Family Physicians — Omaha, Nebraska, United States
• Clinical Research Advantage, Inc. — Omaha, Nebraska, United States
• New Jersey Medical School — Newark, New Jersey, United States
• East Valley Family Physicians — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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