Roche trials database

Trial information

An Influenza Resistance Information Study (IRIS)

Status:

Active, not recruiting

Protocol number:

NV20237

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

An open label study to examine natural prevalence and/or emergence of resistance to antivirals among influenza virus isolates, and of the clinical outcome of patients with influenza: Influenza Resistance Information Study (IRIS)

Brief summary:

This study will assist in the early detection of influenza resistant to antivirals, and will monitor the clinical outcome of patients infected with influenza according to subtype and susceptibility. Patients clinically diagnosed with influenza will undergo a rapid diagnostic test, and viral sampling at baseline and on days 3 and 6. Patients will be clinically managed according to local guidelines (no treatment, or treatment with neuraminidase inhibitors or other appropriate therapies). Target sample size is 4184.

Study phase:

IV

Study type:

Interventional; Diagnostic; Non-randomized; Open label; Uncontrolled; Single group; Efficacy study

Conditions:

• Influenza

Primary outcome:

1. Natural prevalence and/or emergence of resistance to antivirals among influenza virus isolates Time frame: Baseline, and days 3 and 6

Key secondary outcomes:

1. Genotypic and phenotypic characteristics of circulating viral strains Time frame: Baseline, and days 3 and 6
2. Signs and symptoms of patients infected with different subtypes of seasonal influenza Time frame: Baseline, and days 3 and 6
3. Adverse events Time frame: Days 3 and 6

Inclusion criteria:

• patients>=1 year of age;
• symptoms suggestive of influenza-like illness including, but not limited to, fever, cough or coryza.

Exclusion criteria:

• allergy to any potential influenza therapy;
• more than one patient from same household or residential/care home.

Gender:

Males or Females

Age limits:

Min: 1 year Max: N/A N/A

Accepts healthy volunteers:

No

Anticipated start date:

January, 2009

Trial registration date:

14.01.2009

Date last updated:

10.06.2013

This trial was conducted at the following locations:

AUSTRALIA

• Westmead, New S

FRANCE

• Bron

GERMANY

• Berlin

HONG KONG

• Shatin

NETHERLANDS

• Rotterdam

NORWAY

• Sandnes

POLAND

• Krakow

UNITED STATES

• Chicago, IL

Link to trial result