A prospective study to examine the effectiveness and safety of neuraminidase inhibitors in volunteers who receive long-term prophylaxis against pandemic influenza: PIPET B

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000178347

Acronym

PIPET B

Enrollment

1000

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 prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. 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 prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. The study is observational only. The recommended adult dosage of oseltamivir for prophylaxis is 75mg once daily for seven days however safety and efficacy has been demonstrated for up to six weeks. Zanamivir prophylaxis consists of 2 x 5mg doses (inhalations) once daily. This study does not stipulate the dose or duration of the prophylaxis, this will be determined by the treating physician. Within the pandemic environment these listed doses or durations may be different. This study is observational only. The Australian Pandemic Plan outlines that all "workers" at risk of pandemic influenza will be treated with prophylaxis. The workers at risk includes medical staff, border control and customs staff etc. The duration of observation is 6 months.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent 2. Intention to commence, or already commenced prophylaxis with a neuraminidase inhibitor in the context of a place of employment or profession It is anticipated that participants in this study who are subsequently clinically diagnosed with pandemic influenza will be enrolled in the Index Case protocol (PIPET-A) with follow-up as specified.

Exclusion criteria

None

Outcome results