N/A
N=558
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT01314911 ↗Enrolled (actual)
558
Serious AEs
1.3%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples — 99; 131 Participants — p=0.0097
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oseltamivir (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples |
99; 131 | 0.0097 sig |
| SECONDARY Number of Participants by Virus Detection Status--Team Collected Samples |
237; 245; 6; 5; 3; 5 | — |
| SECONDARY qPCR Viral Shedding -- Team Collected Samples |
6.85; 6.9; 3.4; 3.9; 3.2; 3.2 | — |
| SECONDARY Number Of Participants Shedding Virus -- Team Collected Samples |
126; 100; 87; 124; 27; 26 | 0.0243 sig |
| SECONDARY Time to Alleviation of Influenza Clinical Symptoms |
4; 4 | 0.41 |
| SECONDARY Time to Absence of Fever |
1; 1 | 0.88 |
| SECONDARY Time to Resolution of All Symptoms AND Fever |
4.0; 4.0 | 0.7461 |
| SECONDARY Time to Feeling as Good as Before the Onset of the Influenza Illness |
6.0; 6.0 | 0.1501 |
| SECONDARY Time to Return to Pre-influenza Function |
3.5; 5.0 | 0.3025 |
| SECONDARY Time to Return of Physical Function to Pre-illness Level |
7.0; 7.0 | 0.5466 |
| SECONDARY Number of Participants With Treatment Compliance Status |
1; 2; 2; 2; 2; 1 | — |
| SECONDARY Percentage of Participants Who Required Hospitalization. |
1.4; 0.7 | 0.5311 |
| SECONDARY Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0. |
3.2; 1.8; 0.4; 0.4; 2.5; 2.2 | 0.8498 |
| SECONDARY 28-day Mortality |
0; 0 | — |
| SECONDARY Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples |
56; 89 | 0.0021 sig |
| SECONDARY Number of Participants by Virus Detection Status --Self Collected Samples |
217; 225; 11; 6; 17; 23 | — |
| SECONDARY qPCR Viral Shedding -- Self Collected Samples |
6.1; 6.2; 5.5; 6.0; 4.2; 4.5 | — |
| SECONDARY Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples |
12.5; 13.18 | 0.022 sig |
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.
Eligibility 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)
- 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)
Exclusion Criteria
- 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
- 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 was longer) prior to study entry
- Participated in other research protocols that required more than 100mL of blood to be drawn in a 4-week period that overlapped with this study.
Data sourced from ClinicalTrials.gov (NCT01314911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.