EXPECT-1 Includes First Patient

Great news in COMBACTE-NET’s EXPECT-1 study: the very first patient was enrolled in EXPECT-1 on 30 September 2019.

The first patient was enrolled by Dr. Grenaille from Bugeat, France. The EXPECT-1 team is very thankful to the French study team and Dr. Grenaille for reaching this important milestone. There are currently 9 patients enrolled in the study (Last update as of 21st October: 49 patients enrolled) .

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 took place the second week of September. With the first participant expected in the second half of September, EXPECT-1’s first enrollment has been done according to schedule.

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).

About EXPECT

Extraintestinal pathogenic Escherichia coli (ExPEC) are a leading and rising cause of bacterial invasive disease worldwide. The emergence of multidrug resistance among ExPEC strains such as E. coli sequence type 131:O25B, represents a major challenge for the treatment of ExPEC infections. Prevention is becoming more and more important however to date, there is no vaccine available to prevent invasive ExPEC disease (IED).

The EXPECT-1 study is a prospective observational pilot study to assess success factors and barriers for a future Phase 3 randomized controlled trial, where the efficacy of a new vaccine to prevent invasive ExPEC disease will be tested in community-dwelling adults. General practitioners (GPs) in a maximum of 8 countries will be asked to recruit a total of 6,000 study participants (750 per country). These are adults aged 60 years or older in stable health, primarily with a history of urinary tract infections. The objective is to capture any hospitalization, with a focus on hospitalization due to IED, and to identify the clinical and operational challenges that might occur during the Phase 3 vaccine efficacy study.