A prospective study to examine the effectiveness and safety of antivirals in volunteers who receive short-term prophylaxis against pandemic influenza

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000179336

Acronym

PIPET C

Enrollment

500

Registered

2008-04-09

Start date

2008-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This project will commence upon pandemic influenza being declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.

Interventions

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only. The recommended adult dosage for oseltamavir for prophylaxis is 75mg once daily for ten days. Zanamivir prophylaxis consists of two 5mg doses (inhalations) once daily. Zanamivir can be either inhaled or is available intravenously. This protocol does not stipu

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only. The recommended adult dosage for oseltamavir for prophylaxis is 75mg once daily for ten days. Zanamivir prophylaxis consists of two 5mg doses (inhalations) once daily. Zanamivir can be either inhaled or is available intravenously. This protocol does not stipulate the dose or duration to be given to subjects, this will be determined by the treating physician and may differ to that normally indicated due to the pandemic environment. This study is observational only.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

a) Provision of written informed consent b) Intention to commence or have commenced short-term prophylaxis with a neuraminidase inhibitor in individuals who have been exposed to the pandemic virus

Exclusion criteria

None

Outcome results