Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609399
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : June 20, 2018
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE October 27, 2015
First Posted Date  ICMJE November 20, 2015
Results First Submitted Date  ICMJE April 11, 2018
Results First Posted Date  ICMJE June 20, 2018
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE November 1, 2015
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire [ Time Frame: ED Enrollment Visit through Day 14 ( 2015-2016 influenza season) ]
    Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms. Item responses:
    1. Not at all
    2. A little bit
    3. Somewhat
    4. Quite a bit
    5. Very much
  • Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire [ Time Frame: ED Enrollment Visit through Day 14 ( 2016-2017 influenza season) ]
    Symptom evaluation during the 2016-2017 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms. Item responses:
    1. Not at all
    2. A little bit
    3. Somewhat
    4. Quite a bit
    5. Very much
  • Mean Karnofsky Performance Scale Score During the 2015-2016 Influenza Season [ Time Frame: ED Enrollment Visit through Day 14 ( 2015-2016 influenza season) ]
    The Karnofsky Performance Scale is a tool for assessing subject functional impairment. Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal - no complaints, no evidence of disease) from enrollment through Day 14 of the 2015-2016 influenza season.
  • Mean Karnofsky Performance Scale Score During the 2016-2017 Influenza Season [ Time Frame: ED Enrollment Visit through Day 14 ( 2016-2017 influenza season) ]
    The Karnofsky Performance Scale is a tool for assessing subject functional impairment. Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal - no complaints, no evidence of disease) from enrollment through Day 14 of the 2016-2017 influenza season.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Enrollment of high-risk subjects with laboratory-confirmed influenza into a therapeutic study [ Time Frame: 6 months (November 2015 - April 2016) ]
    The number of subjects successfully enrolled
  • Completion of treatment with IV or oral medication in ED [ Time Frame: 6 months (November 2015 - April 2016) ]
    The proportion of subjects who complete treatment with IV or oral medication in the ED
  • Completion of follow-up [ Time Frame: 6 months (November 2015 - April 2016) ]
    The proportion of subjects who complete follow-up
  • Number of subjects with reported symptoms as assessed using the FLU-PRO questionnaire [ Time Frame: 6 months (November 2015 - April 2016) ]
    Symptom evaluation
  • Subjects' level of functioning, as assessed by the Karnofsky Performance Status Scale [ Time Frame: 6 months (November 2015 - April 2016) ]
    Functional assessment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Triage-based assessment and rapid testing algorithm: Screening [ Time Frame: 6 months (November 2015 - April 2016) ]
    The proportion of ED patients who were screened for influenza
  • Triage-based assessment and rapid testing algorithm: Testing Criteria Met [ Time Frame: 6 months (November 2015 - April 2016) ]
    The proportion of screened patients who meet testing criteria
  • Triage-based assessment and rapid testing algorithm: Testing Completed [ Time Frame: 6 months (November 2015 - April 2016) ]
    The proportion of patients who meet testing criteria who were tested for influenza
  • Triage-based assessment and rapid testing algorithm: Identification of Influenza Positive Patients [ Time Frame: 6 months (November 2015 - April 2016) ]
    Proportion of patients tested for influenza who were positive for influenza
  • Retrospective evaluation of eligible patients [ Time Frame: 2 years (November 2015 - September 2017) ]
    The proportion of eligible patients who were enrolled
  • Retrospective evaluation of eligible patients for enrollment biases [ Time Frame: 2 years (November 2015 - September 2017) ]
    Comparison of demographic characteristics between those who were prospectively enrolled versus not
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir
Official Title  ICMJE Influenza Therapeutic Trial: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency Department to High Risk Subjects
Brief Summary

This pilot study is designed to demonstrate the feasibility of utilizing Emergency Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating influenza therapeutics, and to provide pilot data for future clinical trial design and planning.

Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed influenza into a randomized, open label study of oral versus IV influenza therapeutic to include symptom evaluation and outcome assessments.

Secondary Objective 1: To identify influenza positive patients utilizing a previously established triage-based assessment and rapid testing algorithm for suspected influenza infection.

Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for potential enrollment biases.

Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected from ED patients with suspected influenza illness.

Detailed Description

Title: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency Department to High Risk Subjects

Population: Adults presenting to the emergency department (ED) with laboratory confirmed influenza who meet Centers for Disease Control and Prevention (CDC) criteria for antiviral treatment

Informed consent: Written informed consent

Number of Sites: 2 - large, urban, academically-affiliated, US EDs

Study Duration: November 2015 - June 2018

Subject Participation Duration: 4 weeks

Description of Agent or Intervention: Subjects will be randomized to either oral (oseltamivir) or intravenous (IV) (peramivir) antiviral treatment.

Description of Study Design: This is an open-label randomized controlled clinical trial in which subjects with influenza are randomized to either oral (oseltamivir) or IV (peramivir) antiviral treatment.

Estimated Time to Complete Enrollment: Subject enrollment will occur over two influenza seasons (November 2015 - April 2016 and November 2016 - April 2017) or longer, at the Principal Investigator's discretion, based on influenza prevalence.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Influenza
Intervention  ICMJE
  • Drug: Oseltamivir
    Oral
    Other Name: Tamiflu
  • Drug: Peramivir

    IV

    Note: Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician.

    Other Name: Rapivab
Study Arms  ICMJE
  • Experimental: Oseltamivir
    Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
    Intervention: Drug: Oseltamivir
  • Experimental: Peramivir
    Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir.
    Intervention: Drug: Peramivir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
180
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2015)
100
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. 18 years of age or older
    2. Laboratory confirmed positive influenza test associated with their current ED visit
    3. Symptoms of acute respiratory illness for ≤4 days (96 hours)
    4. 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:

  1. Does not speak and understand English (or English or Spanish)
  2. Unable or unwilling to provide informed consent
  3. Previously enrolled in the study during the current influenza season
  4. Unable to take oral medication
  5. Unable to comply with all planned study procedures including availability for follow-up and willingness to complete study diary and self-assessment
  6. Use of neuraminidase inhibitors within the past seven days
  7. Known allergic reaction to neuraminidase inhibitors
  8. Pregnant or breastfeeding
  9. End-stage renal disease, defined as 9a. Currently undergoing dialysis (either hemo or peritoneal); or 9b. Creatinine clearance (CrCl) of <10 mL/min.
  10. End-stage liver disease, as determined by the treating ED provider
  11. Glucose-6-phosphate dehydrogenase (G6PD) deficiency by patient report
  12. 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609399
Other Study ID Numbers  ICMJE IRB00080405
1 IDSEP150026-01-00 ( Other Grant/Funding Number: Department of Health and Human Services )
1 IDSEP160031-01-00 ( Other Grant/Funding Number: Department of Health and Human Services )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Department of Health and Human Services
Investigators  ICMJE
Principal Investigator: Richard Rothman, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP