Trial record 1 of 1 for:
IRC004
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
This study is currently recruiting participants.
Verified May 2013 by National Institute of Allergy and Infectious Diseases (NIAID)
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: May 10, 2013
Last verified: May 2013
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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: | September 2014 (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 |
| 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:
- One or more respiratory symptom (cough, sore throat, or nasal symptoms) and either:
- Fever (subjective or documented ≥ 38.0°C) or
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314911
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| United States, California | |
| University of Southern California 5P21 Rand Schrader Clinic | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Fred Sattler, MD 323-343-8288 fsattler@usc.edu | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Jill Kunkel, RN 619-543-8080 jkunkel@ucsd.edu | |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Michelle Barron, MD 303-724-4939 Michelle.barron@ucdenver.edu | |
| United States, Florida | |
| University of Miami AIDS Clinical Research Unit | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Lillian Colon, RN, BSN 305-243-3838 | |
| DMI Research, Inc. | Recruiting |
| Pinellas Park, Florida, United States, 33782 | |
| Contact: Ingrid Ferro-Slipde, CCRC 727-531-2848 ext 104 oferrp@dmiresearch.com | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Patricia Winokur, MD 319-384-1735 patricia-winokur@uiowa.edu | |
| United States, Kentucky | |
| University of Louisville Hospital | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Kendra Thompson 502-852-8846 Kksear01@louisville.edu | |
| Research Integrity, LLC | Recruiting |
| Owensboro, Kentucky, United States, 42303 | |
| Contact: Timothy Hillard 270-691-1827 thillard@drvora.com | |
| United States, Maryland | |
| National Institutes of Health, Laboratory of Immunoregulation | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Jocelyn Voell 301-435-7913 jvoell@niaid.nih.gov | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Stephanie Marl, BS 313-916-9417 Smarl1@hfhs.org | |
| Principal Investigator: Norman Markowitz, MD | |
| United States, New Jersey | |
| New Jersey Medical School | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Nancy Reilly, RN, MS 973-972-1268 reillyna@umdnj.edu | |
| United States, New York | |
| James J. Peters VA Medical Center | Recruiting |
| Bronx, New York, United States, 10468 | |
| Contact: Fletcher Fernau, BA or Cathy Martyn, NP 718-584-9000 | |
| NYU School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Richard Hutt, RN 212-263-6565 Richard.hutt@nyumc.org | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Dr. John Treanor 585-275-5871 john_treanor@urmc.rochester.edu | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Susan Gagnon 919-668-0178 susan.gagnon@dm.duke.edu | |
| United States, Pennsylvania | |
| University of Pennsylvania, Division of Infectious Disease | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Joseph Quinn, BSN 215-349-8092 Joseph.quinn@uphs.upenn.edu | |
| United States, South Dakota | |
| Health Concepts | Recruiting |
| Rapid City, South Dakota, United States, 57702 | |
| Contact: Lisa Wachendorf, CRC 605-721-5044 Lisaw.research@live.com | |
| United States, Texas | |
| Texas Tech University Health Sciences Center at Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Todd Bell, MD 806-354-5483 Todd.bell@ttuhsc.edu | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Karen Vigil, MD 713-309-0044 Karen.j.vigil@uth.tmc.edu | |
| Texas Tech University Health Sciences Center | Terminated |
| Lubbock, Texas, United States, 79430 | |
| United States, Virginia | |
| University of Virginia, Elson Student Health Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Betsy Lang, RN 434-982-3981 BBL3F@hscmail.mcc.edu | |
| Contact: Birgit Winther, MD 434-924-5934 BW8B@hscmail.mcc.virginia.edu | |
| Virginia Commonwealth University Medical Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Carol Clark, BSN 804-828-2342 csclark@vcu.edu | |
| Contact: Vicky Watson, RN 804-828-3450 vwatson@vcu.edu | |
| Argentina | |
| Hospital Italiano de Buenos Aires | Recruiting |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 01181 | |
| Contact: Laura Barcan, MD (PI) (5411) 4959-0393 laura.barcan@hositalitaliano.org.ar | |
| Hospital General de Agudos J. M. Ramos Mejía | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Juan Ebenrstejin, RN 5411-4931-5252 jebensrtejin@hivramos.org.ar | |
| Centro de Educacion Medica e Investigaciones Clinicas (CEMIC) | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Pablo Bonvehi 5411-5299-1580 ext 2228 pbonvehi@intramed.net.ar | |
| Hospital Público Descentralizado Dr. Guillermo Rawson | Recruiting |
| Cordoba, Argentina, 05000 | |
| Contact: Daniel David, MD 54-3516969363 danielo.david@gmail.com | |
| Hospital Municipal "Prof. Dr. Bernardo A. Houssay" | Recruiting |
| Pcia. De Buenos Aires, Argentina | |
| Contact: Pablo Lucchetti (5411) 4796-7230 pluchetti@stamboulian.com.ar | |
| Thailand | |
| The Bamrasnaradura Infectious Diseases Institute | Recruiting |
| Muang, Nonthaburi, Thailand, 1100 | |
| Contact: Weerawat Manosuthi, MD 66-2-590-3421 drweerawat@hotmail.com | |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Kiat Ruxrungtham, MD, MSc 66-2-652-3040 to 9 ext 107, 147 rkiat@chula.ac.th | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Winai Ratanasuwan, MD 66-24-197388 srwrt@mahidol.ac.th | |
| Khon Kaen University (Department of Medicine) | Recruiting |
| Khon Kaen, Thailand, 40002 | |
| Contact: Ploenchan Chetchotisakd, MD (PI) 66-43-363168 ploencha@kku.ac.th | |
Sponsors and Collaborators
Investigators
| Study Chair: | John Beigel, MD | SAIC 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: | May 10, 2013 |
| 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 Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013