Influenza Clinical Trial
— AVTOfficial title:
A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
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Status | Withdrawn |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 |
Verified date | October 2018 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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McMaster University |
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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