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THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL

RecruitingPhase 3Ages 18 Years - anyAllHellenic Institute for the Study of Sepsis
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * PSP ≥300 ng/ml measured at the Triage Exclusion Criteria: * Deny to consent * Age less than 18 years * Presence of nil, two or three signs of qSOFA * NEWS2 ≥7 * Full-blown sepsis with overt organ dysfunction (defined as need of high flow oxygen or mechanical ventilation or vasopressors) * Pregnancy (pregnancy test either blood or uninary will be conducted at the ED for female patients of reproductive age) or lactation * Hypersensitivity to meropenem, or to any other antibacterial agent that includes meropenem. Severe hypersensitivity to any antibacterial agent belonging to beta lactam class (eg. penicillins or cephalosporins). * Patients receiving probenecid, valproic acid or warfarin. * Documented acute organ dysfunction compatible with sepsis, as reflected by an increase in SOFA-2 score by ≥2 points.
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What it tests

  • Meropenem Infusion
  • Sodium Chloride (NaCl) 0.9 %
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Where

10 sites
Department of Emergency Medicine, G.Gennimatas Athens General Hospital
Athens, Greece
Department of Emergency Medicine, ATTIKON University General Hospital
Athens, Greece
Department of Emergency Medicine, Aghios Panteleimon Nikaia General Hospital
Athens, Greece
Department of Emergency Medicine, Tzaneion Piraeus General Hospital
Piraeus, Greece
Department of Emergency Medicine, Ioannina University General Hospital
Ioannina, Greece
Department of Internal Medicine, Syros General Hospital
Ermoupoli, Greece
Department of Emergency Medicine, AHEPA Thessaloniki University General Hospital
Thessaloniki, Greece
Department of Emergency Medicine, G. Papanikolaou Thessaloniki General Hospital
Thessaloniki, Greece

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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