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

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: NCT02282384
Recruitment Status : Withdrawn (Sites were unable to recruit participants)
First Posted : November 4, 2014
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date October 26, 2018
Study Start Date  ICMJE October 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
non-elective admission to hospital [ Time Frame: up to 28 days following randomization ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
lower respiratory tract infection [ Time Frame: up to 28 days following randomization ]
lower respiratory tract infection including exacerbation of chronic pulmonary disease
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 31, 2014)
  • pneumonia [ Time Frame: up to 28 days following randomization ]
  • neutrophilic bronchitis [ Time Frame: up to 28 days following randomization ]
  • acute sinusitis [ Time Frame: up to 28 days following randomization ]
  • antimicrobial prescriptions [ Time Frame: up to 28 days following randomization ]
  • visits to medical providers [ Time Frame: up to 28 days following randomization ]
    visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately
  • changes in functional status [ Time Frame: up to 3 months from randomization ]
    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
  • absenteeism from work [ Time Frame: up to 28 days from randomization ]
  • additional care or support needed in the home [ Time Frame: up to 3 months following randomization ]
    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.
  • laboratory testing using RT-PCR for influenza [ Time Frame: up to 28 days following randomization ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
Official Title  ICMJE A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Pulmonary Disease
  • Influenza
Intervention  ICMJE
  • Drug: oseltamivir
    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.
    Other Name: Tamiflu
  • Other: Placebo
    Other Name: Calcium Carbonate
Study Arms  ICMJE
  • Experimental: oseltamivir
    75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
    Intervention: Drug: oseltamivir
  • Placebo Comparator: Placebo
    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: Other: Placebo
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2014)
100
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 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 Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT02282384
Other Study ID Numbers  ICMJE AVT-2014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark B Loeb, MD McMaster University
PRS Account McMaster University
Verification Date October 2018

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