A Phase 4 interventional study of oseltamivir and Placebo in Pulmonary Disease and Influenza, sponsored by McMaster University. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by McMaster University · Phase 4, Interventional, and Prevention
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.
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Exclusion Criteria:
75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
Drug: oseltamivir
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
Other: Placebo
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.
Also known as: Tamiflu
Also known as: Calcium Carbonate
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.
Time frame: up to 28 days following randomization
lower respiratory tract infection
lower respiratory tract infection including exacerbation of chronic pulmonary disease
Time frame: up to 28 days following randomization
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
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
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
Time frame: up to 3 months from randomization
absenteeism from work
Time frame: up to 28 days from randomization
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.
Time frame: up to 3 months following randomization
laboratory testing using RT-PCR for influenza
Time frame: up to 28 days following randomization
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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