ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02609399 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oseltamivir (Drug); Peramivir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire |
1.4; 1.9; 1.3; 1.7; 1.2; 1.6 | — |
| PRIMARY Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire |
1.5; 1.5; 1.3; 1.4; 1.3; 1.2 | — |
| PRIMARY Mean Karnofsky Performance Scale Score During the 2015-2016 Influenza Season |
77.1; 73.2 | — |
| PRIMARY Mean Karnofsky Performance Scale Score During the 2016-2017 Influenza Season |
80.0; 79.9 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Eligible patients include all patients who present to the emergency department (ED) between November and April of each influenza season, or later, at the Co-PIs' discretion, based on influenza prevalence, with the following criteria:
- 18 years of age or older
- Laboratory confirmed positive influenza test associated with their current ED visit
- Symptoms of acute respiratory illness for ≤4 days (96 hours)
- Meets CDC criteria for antiviral treatment
- For the purpose of this study, acute respiratory illness is defined as presence of any of the following symptoms: new or increased cough, new or increased shortness of breath, change in sputum production (for adults 65 years or older), sinus pain, nasal congestion, rhinorrhea, sore throat, subjective fever reported at time of triage or documented fever (defined here as ≥ 38 degrees Celsius).
- CDC criteria for influenza antiviral treatment is defined as: being age 65 years old or older, pregnant or less than two weeks postpartum, American Indian or Alaska native, morbid obesity (BMI ≥40), a current resident of nursing home or other chronic-care facility, having chronic pulmonary disease, cardiovascular disease (except hypertension alone), renal disease, hepatic disease, hematologic disease, metabolic disorders, neurologic and neurodevelopment conditions, immunosuppression (including that caused by medications or by HIV infection), being admitted to inpatient or an observation unit, or having a clinical diagnosis of pneumonia (by the ED physician).
Exclusion Criteria
- Does not speak and understand English (or English or Spanish)
- Unable or unwilling to provide informed consent
- Previously enrolled in the study during the current influenza season
- Unable to take oral medication
- Unable to comply with all planned study procedures including availability for follow-up and willingness to complete study diary and self-assessment
- Use of neuraminidase inhibitors within the past seven days
- Known allergic reaction to neuraminidase inhibitors
- Pregnant or breastfeeding
- End-stage renal disease, defined as 9a. Currently undergoing dialysis (either hemo or peritoneal); or 9b. Creatinine clearance (CrCl) of <10 mL/min.
- End-stage liver disease, as determined by the treating ED provider
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency by patient report
- Immunodeficiency, defined as:
12a. Solid organ transplant patients receiving immunosuppression; 12b. Hematopoietic stem cell transplant patients within 12 months of transplant or with ongoing immunosuppression; 12c. Oncology patients who have had chemotherapy within the past 30 days; 12d. Current treatment with steroids equivalent to 10 mg of prednisone or more per day for greater than two weeks; 12e. Rheumatologic patients receiving immunosuppressive therapy; or 12f. HIV patients who meet one of the following criteria: 12fi. Have a cluster of differentiation 4 (CD4) cell count of <200 cells/mm3 within the past 3 months ; 12fii. Not actively receiving highly active antiretroviral therapy (HAART); or 12fiii. Have an absolute lymphocyte count <1.0 x 103 cells/μL conducted at the current ED visit
Data sourced from ClinicalTrials.gov (NCT02609399). 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.