A prospective study to examine the effectiveness and safety of neuraminidase inhibitors in index cases with presumed pandemic influenza infection

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000176369

Acronym

PIPET A

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 in patients who have a clinical diagnosis of pandemic influenza infection. The study is observational only. The primary measure used in this study will be mortality. Symptom severity and duration, treatment limiting side effects, demographic information and resistance 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 in patients who have a clinical diagnosis of pandemic influenza infection. The study is observational only. Recommended dosage of oseltamivir is 75mg orally (capsules) twice daily for five days, starting within 48 hours of symptom onset. Children greater than one year old may be administered a suspension in the following dosages: less than or equal to 15kg to take 30mg twice daily; 15-23kg 45mg twice daily; 23-40kg 60mg twice daily and over 40kg 75mg twice daily. Zanamivir is administered via inhalation and comes in a breath-activated plastic device (diskhaler). The recommended adult dosage of zanamivir is 10mg (2x5mg inhalations) twice daily for five days. Zanamivir is not generally recommended in children less then 5 years old. This study does not stipulate the dose or duration of these drugs, this is to be determined by the treating physician. In the environment of a pandemic the dose and or duration may differ. This is an observational study only. The duration of the observation is one month.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

1. Clinical diagnosis of pandemic influenza (consistent with the applicable clinical case definition) 2. Provision of written informed consent or equivalent 3. Intention to commence treatment with a neuraminidase inhibitor

Exclusion criteria

There are no exclusion criteria.

Outcome results