Influenza clinical research trials

Influenza treatment and the next generation of influenza medication has long been of special interest to Dr Chris Harrison, GP and Medical Co-ordinator at Ochre Health Medical Centre Bruce, Canberra. So when a recent opportunity arose through Paratus Clinical, for Ochre Health to participate in the global research trials of an anti-viral agent for treating influenza, Dr Harrison was happy for his centre to become involved.

As Principal Investigator for the Bruce site, one of six sites across Australia, last weekend Dr Harrison attended an APAC Investigators meeting in Singapore. The APAC Investigators summit provided attendees, made up of international health professionals and scientists, with an intense exposition of the science behind the new compound, along with detailed clinical study protocols and overarching logistics for conducting the study. Named Capstone 2, this trial targets high-risk patients and follows a previous trial, Capstone 1, which focused on healthy patients. The research study is gradually moving around the globe, tracking data from winter flu seasons. Trials in Australia and New Zealand are set to commence in May 2017.

The trials are focused on the performance of a new compound, S-033188; a novel anti-viral agent for influenza given in a single dose. The compound has been developed by the Japanese pharmaceutical company, Shionogi & Co. Limited. Shionogi produces a range of antimicrobial, hyperlipidaemia and antibiotic medicines and is well known for developing Crestor and Claritin. The clinical trial itself consists of each global site conducting a randomised, double-blind, placebo-controlled, phase 3 study of S-033188 as it compares to both the placebo and Osteltamivir (Tamiflu) over five days. Assessments and tests are conducted before and after the trial, with patients monitored intensely for the five key days, and observed for 22 days in total. Patients who participate are also required to record daily health information in an electronic diary, which sends data directly back to the study.

Dr Harrison believes that Shionogi’s new compound has the potential to provide a welcome turning point in the treatment of influenza. In the near future, patients who present with influenza symptoms will be able to undergo a diagnostic test which provides an immediate diagnosis. Effective treatment can then be given in a single dose tablet, and within 24-48 hours most of the symptoms of influenza will have been resolved.

Participating in such a complex trial, conducted through a general practice setting, will place added demands on the centre’s medical staff, particularly the hard-working nurses who will be instrumental in the smooth running of the trial. Dr Harrison is grateful for their involvement in the trial, which will provide Ochre Health with a glimpse into a healthy future, where influenza management will beneficially impact the patients and communities that Ochre Health serves.

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