Early PSP-guided Meropenem in at-risk adults with suspected infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, double-blind, randomized controlled trial evaluating whether PSP-guided early administration of meropenem can lower progression to sepsis and improve survival in adults with suspected infection. Eligible participants are adults with suspected infection and at least one sign indicating higher risk, and PSP testing at triage helps identify those at greater risk. Participants receive a single infusion of meropenem or placebo and are followed through discharge and again at 28 and 90 days to assess outcomes. The study builds on prior evidence suggesting early antibiotic initiation benefits high-risk patients and explores PSP as a biomarker to better target therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Emergency Medicine, ATTIKON University General Hospital
  Athens, Attica, Greece Recruiting
• Department of Emergency Medicine, Aghios Panteleimon Nikaia General Hospital
  Athens, Attica, Greece Recruiting
• Department of Emergency Medicine, Tzaneion Piraeus General Hospital
  Piraeus, Attica, Greece Recruiting
• Department of Emergency Medicine, Ioannina University General Hospital
  Ioannina, Ioannina, Greece Recruiting
• Department of Internal Medicine, Syros General Hospital
  Ermoupoli, Syros, Cyclades, Greece Recruiting
• Department of Emergency Medicine, AHEPA Thessaloniki University General Hospital
  Thessaloniki, Thessaloniki, Greece Recruiting

Study contacts

• Study coordinator: Evangelos J Giamarellos-Bourboulis, Professor
• Email: egiamarel@med.uoa.gr
• Phone: 2105831994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.