AVT: An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: oseltamivir 75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset |
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 Names:
|
| 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 |
Other: Placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- non-elective admission to hospital [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.
Secondary Outcome Measures
- lower respiratory tract infection [up to 28 days following randomization]
lower respiratory tract infection including exacerbation of chronic pulmonary disease
Other Outcome Measures
- pneumonia [up to 28 days following randomization]
- neutrophilic bronchitis [up to 28 days following randomization]
- acute sinusitis [up to 28 days following randomization]
- antimicrobial prescriptions [up to 28 days following randomization]
- visits to medical providers [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 [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 [up to 28 days from randomization]
- additional care or support needed in the home [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 [up to 28 days following randomization]
Eligibility Criteria
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:
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residents of nursing homes
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patients who are immunosuppressed
-
patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- McMaster University
Investigators
- Principal Investigator: Mark B Loeb, MD, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AVT-2014