A randomised controlled trial on the effectiveness of post-exposure prophylaxis (PEP) with oseltamivir in preventing influenza transmission in nursing home units
Completed
- Conditions
- influenza like illness (ILI)1002497010047438flu
- Registration Number
- NL-OMON33181
- Lead Sponsor
- RIVM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4000
Inclusion Criteria
The unit of randomisation will be nursing home units in nursing homes willing to participate, and where virologically confirmed influenza is diagnosed in an index case. In these units, all residents (apart from the index case(s)) and staff are eligible for randomisation to PEP with oseltamivir or PEP with placebo.
Exclusion Criteria
No consent, medical contra-indication to oseltamivir.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Transmission, the primary trial outcome measurement, is defined as a newly<br /><br>laboratory confirmed influenza in the same unit 12 hours or more after the<br /><br>start of PEP.<br /><br>Assuming 30 homes participate, that annually 30% of nursinghomes experience a<br /><br>confirmed influenza outbreak in on average two units, than we can recruit 20<br /><br>units per season. Assuming that without effective prophylaxis ongoing<br /><br>transmission occurs in 40% of the units, we will have at least 80% power after<br /><br>3 seasons with a two-sided alpha=0.05 to demonstrate a reduction in<br /><br>transmission of 70%. </p><br>
- Secondary Outcome Measures
Name Time Method <p>This trial offers an excellent opportunity to evaluate the possible emergence<br /><br>of resistance against oseltamivir if used under such circumstances, by<br /><br>analysing the occurrence of viral mutations under oseltamivir therapy (for<br /><br>index- and for any secondary cases). In addition, we will assess the relative<br /><br>cost-effectiveness of PEP with oseltamivir per nursing home unit, compared to<br /><br>not using PEP by prospectively collecting information on the number of<br /><br>influenza infections and related complications, duration of symptoms, use of<br /><br>medical services by secondary cases, as well as sickness leave of staff.<br /><br>Finally, potential ethical and logistical restrictions for the large scale use<br /><br>of oseltamivir will be documented prospectively</p><br>