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

NCT01314911 | Completed Results DMC

• 3 other identifiers: IRC 00411-I-0031IRC004
• Study Type: interventional
• Target: 716
• Locations: 3 countries
• Sites: 51

Brief 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.

Conditions

Influenza, Human

Keywords

H1N1; Complications; PCR; Seasonal Influenza; Viral Shedding

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples

  The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.

  At Day 3

Secondary Outcomes (17)

• Number of Participants by Virus Detection Status--Team Collected Samples

  At Day 0, 3 and 7

• qPCR Viral Shedding -- Team Collected Samples

  At Day 0, 3 and 7

• Number Of Participants Shedding Virus -- Team Collected Samples

  At day 3 and 7.

• Time to Alleviation of Influenza Clinical Symptoms

  From treatment initiation to Day 28

• Time to Absence of Fever

  From treatment initiation to Day 28

Study Arms (2)

Oseltamivir

EXPERIMENTAL

Drug: Oseltamivir

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oseltamivir DRUG

Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.

Oseltamivir

Placebo DRUG

Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (51)

East Valley Family Physicians

Chandler, Arizona, 85224, United States

Location

WCCT Global, LLC

Costa Mesa, California, 92626, United States

Location

Paragon Rx Clinical

Garden Grove, California, 92840, United States

Location

University of Southern California

Los Angeles, California, 92103, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Advanced Rx Clinical Research Group

Westminster, California, 92683, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610-0186, United States

Location

Best Quality Research, Inc.

Hialeah, Florida, 33106, United States

Location

Medical Consulting Center

Miami, Florida, 33125, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

DMI Research, Inc.

Pinellas Park, Florida, 33782, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Horizon Research Group of Opelousas, LLC

Eunice, Louisiana, 70535, United States

Location

Michael Seep, MD; Centex Studies

Lake Charles, Louisiana, 70601, United States

Location

National Institutes of Health, Laboratory of Immunoregulation

Bethesda, Maryland, 20892, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Skyline Medical Center

Elkhorn, Nebraska, 68022, United States

Location

Prairie Fields Family Medicine

Fremont, Nebraska, 68025, United States

Location

Southwest Family Physicians

Omaha, Nebraska, 68124, United States

Location

Clinical Research Advantage, Inc.

Omaha, Nebraska, 68144, United States

Location

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Great Lakes Medical Research

Westfield, New York, 14787, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

University of Pennsylvania, Division of Infectious Disease

Philadelphia, Pennsylvania, 19104, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Clinical Research Solutions

Franklin, Tennessee, 37067, United States

Location

Clinical Research Solutions

Jackson, Tennessee, 38305, United States

Location

Clinical Research Solutions

Nashville, Tennessee, 37211, United States

Location

Clinical Research Solutions

Smyrna, Tennessee, 37167, United States

Location

University of Texas Tech Amarillo

Amarillo, Texas, 79106, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Centex Studies

Houston, Texas, 77058, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Village Health Partners

Plano, Texas, 75024, United States

Location

Bandera Family Health Care

San Antonio, Texas, 78249, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Hospital General de Agudos J. M. Ramos Mejía

Buenos Aires, Argentina

Location

Hospital Municipal "Prof. Dr. Bernardo A. Houssay"

Buenos Aires, Argentina

Location

Hospital Público Descentralizado Dr. Guillermo Rawson

Córdoba, 05000, Argentina

Location

The Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 1100, Thailand

Location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Khon Kaen University (Department of Medicine)

Khon Kaen, 40002, Thailand

Location

Related Publications (3)

• Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.

  PMID: 12517228 BACKGROUND

• Monto AS. Vaccines and antiviral drugs in pandemic preparedness. Emerg Infect Dis. 2006 Jan;12(1):55-60. doi: 10.3201/eid1201.051068.

  PMID: 16494718 BACKGROUND

• Beigel JH, Manosuthi W, Beeler J, Bao Y, Hoppers M, Ruxrungtham K, Beasley RL, Ison M, Avihingsanon A, Losso MH, Langlois N, Hoopes J, Lane HC, Holley HP, Myers CA, Hughes MD, Davey RT. Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial. Clin Infect Dis. 2020 May 23;70(11):2317-2324. doi: 10.1093/cid/ciz634.

  PMID: 31541242 DERIVED

Related Links

• The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: John Beigel, M.D
• Organization: Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)

jbeigel@niaid.nih.gov

301-451-9881

Study Officials

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 15, 2011
• Study Start: April 1, 2011
• Primary Completion: November 18, 2017
• Study Completion: November 18, 2017
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-01

Locations

US (44); TH (4); AR (3)