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Trial record 47 of 118 for:    oseltamivir

ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

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ClinicalTrials.gov Identifier: NCT02609399
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Results First Posted : June 20, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Influenza Drug: Oseltamivir Drug: Peramivir Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : May 26, 2017
Estimated Study Completion Date : August 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Oseltamivir
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
Drug: Oseltamivir
Oral
Other Name: Tamiflu

Experimental: Peramivir
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir.
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


  4. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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


Information from the National Library of Medicine

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): NCT02609399


Locations
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United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Department of Health and Human Services
Investigators
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Principal Investigator: Richard Rothman, MD, PhD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02609399     History of Changes
Other Study ID Numbers: 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 )
First Posted: November 20, 2015    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: November 30, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Influenza
Antiviral treatment
Emergency department
Influenza therapeutics
Rapid influenza testing
Additional relevant MeSH terms:
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Oseltamivir
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Peramivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action