EXPECT Studies Granted First Ethical Approvals

Over the summer months the EXPECT-1 and EXPECT-2 studies were granted the first ethical approvals in Spain.

In the meantime, the University of Oxford in the UK and the University of Verona in Italy will join the EXPECT studies as new COMBACTE-NET academic partners. The sponsor’s project management visited the two universities’ study teams to discuss the operational aspects for the studies.

The EXPECT studies are managed by ‘local research teams’ led by COMBACTE partners such as Prof. Dr. Jesús Rodriguez-Baño (University Hospital of Seville, Spain), Prof. Dr. Oliver Cornely (University of Cologne, Germany), Prof. Dr. Evelina Tacconelli (University of Verona, Italy), Dr. Olivier Barraud (CHU Limoges, France), and Prof. Christopher Butler (University of Oxford, United Kingdom) and other collaborating parties in Japan, USA and Canada.

The first Clinical Research Associate (CRA) training took place on 29th of August. The site selection is near completion, with France and Spain having finalized this study phase in June.
The EXPECT-1 study is the first COMBACTE study in which participants are enrolled in primary healthcare through close collaboration of the local research teams with general practice networks. Study participants are community-dwelling people in stable health aged 60 years and older. The first site initiation visit is planned for the second week of September, and the first participant expected in the second half of September.

Janssen Vaccines and Prevention will be working together with local study teams in several countries to trial novel mobile technology. This technology – an application on participants’ mobile phones – aims to promote continuous engagement of participants in the EXPECT-1 study. It also provides alerts to the participant when they enter a hospital. The ultimate goal is to retain participants in the study for the full study period, and to capture all participants’ hospital visits, including those of participants that develop invasive ExPEC diseases (IED).

EXPECT-2 is a prospective epidemiological study in the same hospitals participating in the EXPECT-1 study. In addition to participants enrolled by GPs in EXPECT-1, a total of 240 patients with confirmed IED (30 patients per country) will be enrolled in EXPECT-2. The aim is to estimate the O-serotype distribution of ExPEC isolated from hospitalized patients aged 60 years or older with IED, and to evaluate the clinical case definition and risk factors. COMBACTE’s LAB-Net based at the University of Antwerp, and the Universitair Ziekenhuis Antwerpen are serving as the Central Laboratory for EXPECT-2.