ViroGates A/S announces positive results of a randomized controlled clinical trial on suPAR-guided antibiotic treatment in sepsis presented today, Friday the 22nd of September 2023, at the European Shock Conference in Vienna, Austria by Dr Maria Adami from the Hellenic Sepsis Group. Sepsis is a deadly disease and is estimated to account for around 11 million deaths annually. Early treatment is pivotal but often not initiated, as early diagnosis is missed.

Current guidelines suggest that patients admitted to the emergency department should be treated for sepsis if they have at least two of three signs of risk for sepsis (2 or 3 points in the qSOFA score system). However, if a patient has only one sign of risk, treatment is often delayed to limit the use of unnecessary antibiotics. However, some patients with only one risk sign require early treatment to prevent progression and the challenge is to find the ones that benefit from early treatment.

It has previously been shown that suPAR is a strong prognostic biomarker in sepsis, and during the COVID-19 pandemic, suPAR-guided treatment with anakinra was shown to reduce progression to respiratory failure. Today, Dr Maria Adami, on behalf of the Hellenic Sepsis Group, has reported the results of the SUPERIOR double-blinded, randomized clinical trial, recruiting patients with suspected infections visiting the ED from two hospitals in Greece, presenting with one risk sign (1 point in the qSOFA score) and a suPAR level equal to or above 12 ng/ml. 1650 patients were screened for their suPAR level in the ED using suPARnostic® and 91 patients with a qSOFA score of 1 and suPAR equal to or above 12 ng/ml were randomized to receive either one dose of meropenem, an antibiotic treatment (44 patients), or one dose of placebo (47 patients).

The study met its primary endpoint: Meropenem treatment guided by suPARnostic® was accompanied by significantly lower odds for progression into sepsis compared to placebo (OR: 0·28, 95% CI 0·10 ­ 0·76, p = 0·012). An additional significant benefit for patients treated early with meropenem was a relative decrease in their SOFA score on day 2 and a significantly faster recovery from the infection. The SUPERIOR study shows that the measurement of suPAR in patients with one risk sign (1 point of qSOFA score) identifies a subgroup of patients at high risk of an unfavorable outcome and early deterioration if not treated.

These patients receive significant benefits from early meropenem treatment, guided by suPARnostic®. The SUPERIOR trial is chaired by Professor Evangelos J. Giamarellos-Bourboulis from The National and Kapodistrian University of Athens and President of the Hellenic Institute for the Study of Sepsis.