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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza, Human

Intervention: Oseltamivir (Drug); Oseltamivir Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
John Beigel, MD, Study Chair, Affiliation: Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, National Institutes of Health
Michael Ison, MD, MS, Study Chair, Affiliation: Division of Infectious Disease, Feinberg School of Medicine, Northwestern University

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Primary endpoint will be determined after analysis of the pilot study, which will include the first 50 participants enrolled in the study

Secondary outcome:

Time to alleviation of influenza clinical symptoms

Time to absence of fever

Time to resumption of normal activity

Number of premature study treatment discontinuations

Proportion of participants who develop bronchitis, pneumonia, or other complications of influenza

Proportion of participants who require hospitalization

28-day mortality

Duration of viral shedding

Change in viral shedding as a function of time

Area under the curve (AUC) of viral shedding

Frequency of emergence of antiviral resistance

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

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

Centro de Educacion Medica e Investigaciones Clinicas (CEMIC), Buenos Aires, Argentina; Recruiting
Pablo Bonvehi, Phone: 5411-5299-1580, Ext: 2228, Email: pbonvehi@intramed.net.ar

Hospital General de Agudos J. M. Ramos Mejía, Buenos Aires, Argentina; Recruiting
Juan Ebenrstejin, RN, Phone: 5411-4931-5252, Email: jebensrtejin@hivramos.org.ar

Hospital Público Descentralizado Dr. Guillermo Rawson, Cordoba 05000, Argentina; Recruiting
Daniel David, MD, Phone: 54-3516969363, Email: danielo.david@gmail.com

Hospital Municipal "Prof. Dr. Bernardo A. Houssay", Pcia. De Buenos Aires, Argentina; Recruiting
Pablo Lucchetti, Phone: (5411) 4796-7230, Email: pluchetti@stamboulian.com.ar

Siriraj Hospital, Bangkok 10700, Thailand; Recruiting
Winai Ratanasuwan, MD, Phone: 66-24-197388, Email: srwrt@mahidol.ac.th

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, Thailand; Recruiting
Kiat Ruxrungtham, MD, MSc, Phone: 66-2-652-3040 to 9, Ext: 107, 147, Email: rkiat@chula.ac.th

Khon Kaen University (Department of Medicine), Khon Kaen 40002, Thailand; Recruiting
Ploenchan Chetchotisakd, MD (PI), Phone: 66-43-363168, Email: ploencha@kku.ac.th

Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, Buenos Aires 01181, Argentina; Recruiting
Laura Barcan, MD (PI), Phone: (5411) 4959-0393, Email: laura.barcan@hositalitaliano.org.ar

WCCT Global, LLC, Costa Mesa, California 92626, United States; Terminated

Torrance Clinical Research Institute, Inc., Lomita, California 90717, United States; Terminated

University of Southern California 5P21 Rand Schrader Clinic, Los Angeles, California 90033, United States; Active, not recruiting

University of California, San Diego, San Diego, California 92103, United States; Terminated

Westlake Medical Research, Thousand Oaks, California 91360, United States; Active, not recruiting

University of Colorado, Aurora, Colorado 80045, United States; Active, not recruiting

Best Quality Research, Inc., Hialeah, Florida 33106, United States; Active, not recruiting

Medical Consulting Center, Miami, Florida 33125, United States; Terminated

San Marcus Research Clinic, Miami, Florida 33015, United States; Active, not recruiting

Suncoast Research Group, LLC, Miami, Florida 33135, United States; Terminated

University of Miami AIDS Clinical Research Unit, Miami, Florida 33136, United States; Terminated

DMI Research, Inc., Pinellas Park, Florida 33782, United States; Active, not recruiting

Sneeze, Wheeze & Itch Associates, LLC, Normal, Illinois 61761, United States; Withdrawn

University of Iowa, Iowa City, Iowa 52242, United States; Active, not recruiting

University of Louisville Hospital, Louisville, Kentucky 40202, United States; Completed

Research Integrity, LLC, Owensboro, Kentucky 42303, United States; Terminated

Horizon Research Group of Opelousas, LLC, Eunice, Louisiana 70535, United States; Withdrawn

National Institutes of Health, Laboratory of Immunoregulation, Bethesda, Maryland 20892, United States; Active, not recruiting

Henry Ford Hospital, Detroit, Michigan 48202, United States; Active, not recruiting

Bronson Healthcare Group, Kalamazoo, Michigan 49007, United States; Withdrawn

Skyline Medical Center, Elkhorn, Nebraska 68022, United States; Active, not recruiting

Prairie Fields Family Medicine, Fremont, Nebraska 68025, United States; Active, not recruiting

Southwest Family Physicians, Omaha, Nebraska 68124, United States; Terminated

New Jersey Medical School, Newark, New Jersey 07103, United States; Withdrawn

James J. Peters VA Medical Center, Bronx, New York 10468, United States; Active, not recruiting

Mount Sinai Medical Center, New York, New York 10029, United States; Terminated

NYU School of Medicine, New York, New York 10016, United States; Withdrawn

University of Rochester Medical Center, Rochester, New York 14642, United States; Terminated

The Bamrasnaradura Infectious Diseases Institute, Muang, Nonthaburi 1100, Thailand; Recruiting
Weerawat Manosuthi, MD, Phone: 66-2-590-3421, Email: drweerawat@hotmail.com

Duke University Medical Center, Durham, North Carolina 27710, United States; Withdrawn

University of Pennsylvania, Division of Infectious Disease, Philadelphia, Pennsylvania 19104, United States; Active, not recruiting

Health Concepts, Rapid City, South Dakota 57702, United States; Terminated

University of Texas Tech Amarillo, Amarillo, Texas 79106, United States; Completed

Pioneer Research Solutions, Inc., Houston, Texas 77098, United States; Completed

University of Texas Health Science Center at Houston, Houston, Texas 77030, United States; Completed

Texas Tech University Health Sciences Center, Lubbock, Texas 79430, United States; Terminated

Bandera Family Health Care, San Antonio, Texas 78249, United States; Active, not recruiting

University of Virginia, Elson Student Health Center, Charlottesville, Virginia 22908, United States; Active, not recruiting

Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, United States; Terminated

Additional Information

Related publications:

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.

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

Starting date: April 2011
Last updated: December 15, 2014

Page last updated: August 23, 2015

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