Prospective study to assess the emergence of drug resistance to oseltamivir following treatment of acute influenza A among children - Oseltamivir resistance study

niversity Hospitals Leicester, Leicester General Hospital0 sites100 target enrollmentDecember 2, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 2, 2005

End Date

October 1, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity Hospitals Leicester, Leicester General Hospital

•Inclusion criteria
•Boys and girls must satisfy the following to qualify for the study:
•1\. Aged between \>1 and 12 years
•2\. Parents or legal guardians willing to give written informed consent
•3\. Presenting within 48 hours of onset of an acute febrile illness including acute respiratory tract illness, febrile seizure, febrile gastrointestinal illness, acute febrile illness with temp \>38oC
•4\. Willing for post treatment sampling to be conducted
•5\. Able to adhere with oseltamivir treatment (5 days b.d dosing with paediatric suspension)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no

•Exclusion criteria
•1\. unable to obtain informed consent
•2\. conditions presenting with: rash, known bacterial aetiology, non\-respiratory conditions with known aetiology, allergy to oseltamivir
•3\. presence of underlying condition requiring dose alteration of oseltamivir e.g. severe renal failure
•4\. Concomitant therapy requiring oseltamivir dose alteration including methotrexate and probenecid
•5\. inability to obtain nasopharyngeal sample for analysis
•6\. concurrent enrollment in any therapeutic intervention studies