A Randomised Controlled Trial on the Effect of Post-exposure Oseltamivir Prophylaxis on Influenza Transmission in Nursing Homes

NCT01053377 | Unknown Phase 4 DMC

• 1 other identifier: NL27938.041.09
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of severe morbidity and mortality following an influenza infection during the annual influenza epidemics is highest among the elderly population and 90% of influenzaassociated mortality occurs in this group. Vaccination is considered the best preventive intervention available but offers only partial protection. The protective effect decreases with advancing age and existing co-morbidity. Therefore, in spite of high compliance with vaccination, the risk of influenza-related complications among nursing-home residents, is particularly high, and consequently also the associated disease and economic burden. There is debate on the potential health benefit of the antiviral activity of oseltamivir as an effective supplementary intervention to prevent or contain influenza outbreaks in nursing homes. Although effectiveness of post-exposure prophylaxis (PEP) with oseltamivir on preventing transmission has been demonstrated in trials among healthy (mainly unvaccinated) adults and children, effectiveness has not yet been assessed among vulnerable vaccinated highrisk groups, such as the elderly population in nursing homes. If proven (cost)effective, oseltamivir could have considerable benefits in this setting, although constraints relating to implementation need to be addressed as well.

Conditions

Influenza

Keywords

Influenza; Tamiflu; Osteltamivir; Transmission; Prevention; Resistance; Post-Exposure Profylaxe

Outcome Measures

Primary Outcomes (1)

• Transmission of influenza from person to person

  3 months

Study Arms (2)

Tamiflu

ACTIVE COMPARATOR

Drug: Tamiflu (verum)

Placebo Tamiflu

PLACEBO COMPARATOR

Drug: Tamiflu placebo

Interventions

Tamiflu (verum) DRUG

Tamiflu

Tamiflu placebo DRUG

Placebo Tamiflu

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Kidney dialyses

Sponsors & Collaborators

• National Institute for Public Health and the Environment (RIVM): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Institute of Public Health and the Environment

Bilthoven, Utrecht, 3720 BA, Netherlands

Location

Related Links

• Research site

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 21, 2010

Record last verified: 2009-12

Locations

NL (1)