The goal of this clinical trial is to demonstrate the clinical benefit of early intervention with meropenem in adult patients of both sexes with suspected infection and risk of sepsis. The primary objective is to evaluate the clinical benefit of a protein called Pancreatic Stone Protein (PSP), which, if elevated, indicates that patient may be at increased risk of developing sepsis. The secondary objectives are to investigate the impact of early antibiotic treatment with meropenem on progression to sepsis, survival and mortality. Researchers will compare meropenem to a placebo (a look-alike substance that contains no drug).
Participants will:
* Take a single dose of meropenem or a placebo * Be evaluated at designated timepoints post administration until their discharge and, also, on days 28 and 90 post administration, respectively.
Written informed consent
Adult (≥18 years) patients of both sexes
Infection suspicion defined as the presence of at least one of: i) fever ≥38°C; ii) tachycardia (>90 beats/min); iii) acute presence of shortness of breath or dysuria, or diarrhea or abdominal pain; and iv) complaints that according to investigator's discretion indicate/are correlated with the presence of infection
Presence of only one of qSOFA signs (mental confusion, systolic blood pressure less than 100mmHg, respiratory rate more than 22 breaths/min) OR NEWS2 equal to 5 or 6. It is explicitly stated that patients with 0 qSOFA signs may be enrolled in the study if the NEWS2 is 5 or 6. It is also explicitly stated that patients with NEWS2 less than 5 may be enrolled in the study if qSOFA is equal to one.
Deny to consent
Age less than 18 years
Presence of nil, two or three signs of qSOFA
NEWS2 ≥7
Parallel
Meropenem Infusion
DrugThere is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.
Sodium Chloride (NaCl) 0.9 %
DrugThere is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.
28-day mortality
All-cause mortality, defined as death from any cause occurring within 28 days after administration of the study intervention.
Progression to organ dysfunction
Proportion of participants with an increase of ≥2 points in the total Sequential Organ Failure Assessment 2 (SOFA-2) score during the first 24 hours after administration of the study intervention. Participants with infection who meet this criterion will also be classified as meeting the Sepsis-3 definition of sepsis.
Change in total SOFA-2 score
Change in total sequential organ failure assessment-2 (SOFA-2) score from baseline following administration of the study intervention.
Time to stop of antibiotics
Time from administration of the study intervention to discontinuation of antibiotics initiated at the discretion of the treating physician.
Duration of hospitalization
Number of days from hospital admission to hospital discharge.
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