Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
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|ClinicalTrials.gov Identifier: NCT01314911|
Recruitment Status : Active, not recruiting
First Posted : March 15, 2011
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Drug: Oseltamivir Drug: Oseltamivir Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Double-Blind Study Comparing Oseltamivir Versus Placebo for the Treatment of Influenza in Low Risk Adults|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||June 2019|
Participants will receive oseltamivir twice a day for 5 days.
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
- Primary Endpoint is the percentage of subjects shedding virus by PCR in NP swab at day 3. [ Time Frame: Measured at Day 3 ]
- Time to alleviation of influenza clinical symptoms [ Time Frame: Measured at Day 28 ]
- Time to absence of fever [ Time Frame: Measured at Day 28 ]
- Time to resumption of normal activity [ Time Frame: Measured at Day 28 ]
- Number of premature study treatment discontinuations [ Time Frame: Measured at Day 28 ]
- Proportion of participants who develop bronchitis, pneumonia, or other complications of influenza [ Time Frame: Measured at Day 28 ]
- Proportion of participants who require hospitalization [ Time Frame: Measured at Day 28 ]
- 28-day mortality [ Time Frame: Measured at Day 28 ]
- Duration of viral shedding [ Time Frame: Measured at Day 28 ]
- Change in viral shedding as a function of time [ Time Frame: Measured at Day 28 ]
- Area under the curve (AUC) of viral shedding [ Time Frame: Measured at Day 28 ]
- Frequency of emergence of antiviral resistance [ Time Frame: Measured at Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314911
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|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|