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

Influenza Clinical Trial

— AVT  

Official title:

A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02282384
• Other study ID #: AVT-2014
• Status: Withdrawn
• Phase: Phase 4
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Influenza
• Lung Diseases
• Pulmonary Disease

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