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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01314911
First received: March 3, 2011
Last updated: December 15, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention
Influenza, Human
Drug: Oseltamivir
Drug: Oseltamivir Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Study Comparing Oseltamivir Versus Placebo for the Treatment of Influenza in Low Risk Adults

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Primary endpoint will be determined after analysis of the pilot study, which will include the first 50 participants enrolled in the study [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to alleviation of influenza clinical symptoms [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Time to absence of fever [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Time to resumption of normal activity [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Number of premature study treatment discontinuations [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Proportion of participants who develop bronchitis, pneumonia, or other complications of influenza [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Proportion of participants who require hospitalization [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • 28-day mortality [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Duration of viral shedding [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Change in viral shedding as a function of time [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) of viral shedding [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]
  • Frequency of emergence of antiviral resistance [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oseltamivir
Participants will receive oseltamivir twice a day for 5 days.
Drug: Oseltamivir
One capsule twice daily of 75 mg oseltamivir; total dose: 150 mg/day for 5 days
Placebo Comparator: Oseltamivir Placebo
Participants will receive oseltamivir placebo twice a day for 5 days.
Drug: Oseltamivir Placebo
One capsule twice daily of oseltamivir placebo; total dose: 2 placebo capsules/day for 5 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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) and either:
    2. Fever (subjective or documented ≥ 38.0°C) or
    3. One or more constitutional symptom (headache, malaise, myalgia, sweats/chills, or fatigue)
  • Onset of illness no more than 48 hours before screening, defined as when the participant experienced at least one respiratory symptom and constitutional symptom or fever
  • 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)

Exclusion Criteria:

  • Hospitalization at the time of screening
  • Presence of a medical condition(s) that has been associated with increased risk of complications from influenza

    1. Age 65 years of age or older
    2. Asthma
    3. 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)
    4. Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] or cystic fibrosis)
    5. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
    6. Blood disorders
    7. Endocrine disorders (such as diabetes mellitus)
    8. Kidney disorders
    9. Liver disorders
    10. Metabolic disorders (such as inherited metabolic disorders or mitochondrial disorders)
    11. 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)
    12. Pregnant or 4 weeks postpartum
    13. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314911

  Hide Study Locations
Locations
United States, California
WCCT Global, LLC
Costa Mesa, California, United States, 92626
Torrance Clinical Research Institute, Inc.
Lomita, California, United States, 90717
University of Southern California 5P21 Rand Schrader Clinic
Los Angeles, California, United States, 90033
University of California, San Diego
San Diego, California, United States, 92103
Westlake Medical Research
Thousand Oaks, California, United States, 91360
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Best Quality Research, Inc.
Hialeah, Florida, United States, 33106
San Marcus Research Clinic
Miami, Florida, United States, 33015
Medical Consulting Center
Miami, Florida, United States, 33125
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States, 33136
DMI Research, Inc.
Pinellas Park, Florida, United States, 33782
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Research Integrity, LLC
Owensboro, Kentucky, United States, 42303
United States, Maryland
National Institutes of Health, Laboratory of Immunoregulation
Bethesda, Maryland, United States, 20892
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Nebraska
Skyline Medical Center
Elkhorn, Nebraska, United States, 68022
Prairie Fields Family Medicine
Fremont, Nebraska, United States, 68025
Southwest Family Physicians
Omaha, Nebraska, United States, 68124
United States, New York
James J. Peters VA Medical Center
Bronx, New York, United States, 10468
Mount Sinai Medical Center
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
University of Pennsylvania, Division of Infectious Disease
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Texas
University of Texas Tech Amarillo
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77098
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Bandera Family Health Care
San Antonio, Texas, United States, 78249
United States, Virginia
University of Virginia, Elson Student Health Center
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 01181
Centro de Educacion Medica e Investigaciones Clinicas (CEMIC)
Buenos Aires, Argentina
Hospital General de Agudos J. M. Ramos Mejía
Buenos Aires, Argentina
Hospital Público Descentralizado Dr. Guillermo Rawson
Cordoba, Argentina, 05000
Hospital Municipal "Prof. Dr. Bernardo A. Houssay"
Pcia. De Buenos Aires, Argentina
Thailand
The Bamrasnaradura Infectious Diseases Institute
Muang, Nonthaburi, Thailand, 1100
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Siriraj Hospital
Bangkok, Thailand, 10700
Khon Kaen University (Department of Medicine)
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: John Beigel, MD Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, National Institutes of Health
Study Chair: Michael Ison, MD, MS Division of Infectious Disease, Feinberg School of Medicine, Northwestern University
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01314911     History of Changes
Other Study ID Numbers: IRC 004  11-I-0031  IRC004 
Study First Received: March 3, 2011
Last Updated: December 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
H1N1
Complications
PCR
Seasonal Influenza
Viral Shedding

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016