flu influenza like illness (ILI)
Conditions
Interventions
Post-exposition prophylaxis with oseltamivir or placebo.
Once laboratory confirmation has been obtained in an index case, all residents
and staff of that implicated unit only will be randomly assigne
Sponsors
RIVM
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: No consent, medical contra-indication to oseltamivir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transmission, the primary trial outcome measurement, is defined as a newly laboratory confirmed influenza in the same unit 12 hours or more after the start of PEP. Assuming 30 homes participate, that annually 30% of nursinghomes experience a confirmed influenza outbreak in on average two units, than we can recruit 20 units per season. Assuming that without effective prophylaxis ongoing transmission occurs in 40% of the units, we will have at least 80% power after 3 seasons with a two-sided alpha=0.05 to demonstrate a reduction in transmission of 70%. | — |
Secondary
| Measure | Time frame |
|---|---|
| This trial offers an excellent opportunity to evaluate the possible emergence of resistance against oseltamivir if used under such circumstances, by analysing the occurrence of viral mutations under oseltamivir therapy (for index- and for any secondary cases). In addition, we will assess the relative cost-effectiveness of PEP with oseltamivir per nursing home unit, compared to not using PEP by prospectively collecting information on the number of influenza infections and related complications, duration of symptoms, use of medical services by secondary cases, as well as sickness leave of staff. Finally, potential ethical and logistical restrictions for the large scale use of oseltamivir will be documented prospectively | — |
Countries
Netherlands
Outcome results
None listed