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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02282384
Other study ID # AVT-2014
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date October 2014
Est. completion date March 2015

Study information

Verified date October 2018
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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:
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Outcome

Type Measure Description Time frame Safety issue
Other pneumonia up to 28 days following randomization
Other neutrophilic bronchitis up to 28 days following randomization
Other acute sinusitis up to 28 days following randomization
Other antimicrobial prescriptions up to 28 days following randomization
Other visits to medical providers visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately up to 28 days following randomization
Other changes in functional status 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 up to 3 months from randomization
Other absenteeism from work up to 28 days from randomization
Other additional care or support needed in the home 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. up to 3 months following randomization
Other laboratory testing using RT-PCR for influenza up to 28 days following randomization
Primary 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. up to 28 days following randomization
Secondary lower respiratory tract infection lower respiratory tract infection including exacerbation of chronic pulmonary disease up to 28 days following randomization
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