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An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study. (AVT)

Primary Purpose

Pulmonary Disease, Influenza

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
oseltamivir
Placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinic patients with physician diagnosed chronic obstructive pulmonary disease
  • respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per American Thoracic Society guidelines)
  • Participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness

Exclusion Criteria:

  • residents of nursing homes
  • patients who are immunosuppressed
  • patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    oseltamivir

    Placebo

    Arm Description

    75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset

    75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir

    Outcomes

    Primary Outcome Measures

    non-elective admission to hospital
    A non-elective admission to hospital, in contrast to visits to the emergency department where admission does not take place. However, a prolonged stay in the emergency department (> 24 hours) will also be considered to be hospitalization. Events that occur beyond this time period are deemed unlikely to be directly related to influenza,except functional status which will be assessed up to three months following acute respiratory infection. Secondly, the hospitalization must also be considered to be due to acute respiratory illness. An adjudication committee (comprised of two infectious diseases physicians who also practice general internal medicine) blinded to study group allocation will review data for hospitalization. They will be asked to judge whether the hospitalization was definitely or probably related to the acute respiratory illness. Those judged to be definitely or probably related will be considered as our primary outcome.

    Secondary Outcome Measures

    lower respiratory tract infection
    lower respiratory tract infection including exacerbation of chronic pulmonary disease

    Full Information

    First Posted
    September 2, 2014
    Last Updated
    October 25, 2018
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02282384
    Brief Title
    An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
    Acronym
    AVT
    Official Title
    A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sites were unable to recruit participants
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University

    4. Oversight

    5. Study Description

    Brief Summary
    The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease, Influenza

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oseltamivir
    Arm Type
    Experimental
    Arm Description
    75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir
    Intervention Type
    Drug
    Intervention Name(s)
    oseltamivir
    Other Intervention Name(s)
    Tamiflu
    Intervention Description
    They will be assessed for eligibility at the clinics and those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. Participants randomized to the control group will receive calcium carbonate placebo pills twice daily for five days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Calcium Carbonate
    Primary Outcome Measure Information:
    Title
    non-elective admission to hospital
    Description
    A non-elective admission to hospital, in contrast to visits to the emergency department where admission does not take place. However, a prolonged stay in the emergency department (> 24 hours) will also be considered to be hospitalization. Events that occur beyond this time period are deemed unlikely to be directly related to influenza,except functional status which will be assessed up to three months following acute respiratory infection. Secondly, the hospitalization must also be considered to be due to acute respiratory illness. An adjudication committee (comprised of two infectious diseases physicians who also practice general internal medicine) blinded to study group allocation will review data for hospitalization. They will be asked to judge whether the hospitalization was definitely or probably related to the acute respiratory illness. Those judged to be definitely or probably related will be considered as our primary outcome.
    Time Frame
    up to 28 days following randomization
    Secondary Outcome Measure Information:
    Title
    lower respiratory tract infection
    Description
    lower respiratory tract infection including exacerbation of chronic pulmonary disease
    Time Frame
    up to 28 days following randomization
    Other Pre-specified Outcome Measures:
    Title
    pneumonia
    Time Frame
    up to 28 days following randomization
    Title
    neutrophilic bronchitis
    Time Frame
    up to 28 days following randomization
    Title
    acute sinusitis
    Time Frame
    up to 28 days following randomization
    Title
    antimicrobial prescriptions
    Time Frame
    up to 28 days following randomization
    Title
    visits to medical providers
    Description
    visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately
    Time Frame
    up to 28 days following randomization
    Title
    changes in functional status
    Description
    This outcome will be measured using Activities of Daily Living (ADL) score, an index of independence of activities of daily living. Will be assessed at baseline, 2 weeks, 1 month, 3 months after acute respiratory infection onset
    Time Frame
    up to 3 months from randomization
    Title
    absenteeism from work
    Time Frame
    up to 28 days from randomization
    Title
    additional care or support needed in the home
    Description
    Need for new or additional informal caregiver support in the home, need for professional help in the home, transfer to a residential facility, need for rehabilitation for up to 3 months.
    Time Frame
    up to 3 months following randomization
    Title
    laboratory testing using RT-PCR for influenza
    Time Frame
    up to 28 days following randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinic patients with physician diagnosed chronic obstructive pulmonary disease respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per American Thoracic Society guidelines) Participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness Exclusion Criteria: residents of nursing homes patients who are immunosuppressed patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark B Loeb, MD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.

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