More Progress in COMBACTE-NET’s EXPECT Studies

EXPECT-1 and EXPECT-2 are the newest trials in the COMBACTE-NET consortium. EXPECT stands for EXtraintestinal Pathogenic Escherichia Coli Trial. University Medical Centre Utrecht is the sponsor of the study, and Janssen Vaccines and Prevention the EFPIA lead.

The study team is pleased to announce that the study protocols have been finalized. Site selection is well on its way in the eight target countries, with France and Spain being the first to finalize this study phase.

The EXPECT-1 study is the first COMBACTE study in which participants are enrolled in primary healthcare through close collaboration of the local study teams with general practice networks. Study participants are community-dwelling people in stable health aged 60 years and older. The first site initiation visits are expected to take place at the end of July 2019. The first enrollments are expected shortly thereafter in the third quarter of 2019.

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.