South East Asia Influenza Clinical Research Network

The South East Asia Infectious Disease Clinical Research Network, SEA ICRN, is an international, multidisciplinary collaborative partnership funded through Oxford University by NIAID (National Institute of Allergy & Infectious Diseases). SEA ICRN is committed to advancing clinical research and management of infectious diseases, particularly human influenza due to avian or human viruses, while building individual and institutional capacity in international partners. Partners include hospitals and institutions in Thailand (including Mahidol-Oxford Tropical medicine research Unit) , Vietnam, Indonesia (University of Indonesia), UK (Oxford University and the Wellcome Trust), US (NIAID), and the World Health Organisation,. Capacity building in each of the Network’s partner hospitals, laboratories, and hospital pharmacies is done in compliance with internationally recognized GCP and GPP guidelines.

The initial study sponsored by SEA ICRN, “Pharmacologic Study of Oseltamivir in Healthy Volunteers”, is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.

The first intercountry study being executed by SEA ICRN, “High Dose Vs. Standard Dose Oseltamivir in Influenza” is a Phase II prospective, double-blind, randomized trial comparing a two-fold higher to a standard dose of oseltamivir in both severe and avian influenza of hospitalized children and adults. Eleven hospitals in the region (in Thailand, Vietnam and Indonesia) are expected to begin enrolling patients in February 2007. This study will further our understanding of influenza diagnosis, pathogenesis, and responses to antiviral therapy.

Future studies under discussion include Phase I “Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects”, potential of other antiviral drugs, and the potential of treating health care workers with a combination of inhaler and oral antiviral therapy.