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Sodium Chloride (NaCl) 0.9 % / Meropenem Infusion / Sepsis · Phase 3 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 RCT protocol comparing PSP-guided early meropenem against placebo in adult patients with suspected infection and sepsis risk, with 28-day mortality as the primary outcome. No results have been posted in this registry record; the trial has not yet begun recruitment. The design is appropriate for a definitive sepsis intervention trial, but all outcome data remain pending.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Sepsis; age from 18 Years. Intervention: Meropenem. Compared with: Placebo — Placebo Comparator. n = 398. 10 sites: Greece.
This is a registered Phase 3 RCT protocol comparing PSP-guided early meropenem against placebo in adult patients with suspected infection and sepsis risk, with 28-day mortality as the primary outcome. No results have been posted in this registry record; the trial has not yet begun recruitment. The design is appropriate for a definitive sepsis intervention trial, but all outcome data remain pending.
This is a registry record; no results are reported and no efficacy or safety data are available. No effect sizes, confidence intervals, p-values, or mortality rates are provided.
The source did not state who this applies to in practice.
This is a registered but not-yet-recruiting Phase 3 RCT with no results posted; the design is sound but conduct and outcomes remain unknown.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07813767). This is a study registration, not published results. Lead sponsor: Hellenic Institute for the Study of Sepsis. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 398 participants (ESTIMATED). Conditions: Sepsis. Interventions: DRUG: Meropenem Infusion; DRUG: Sodium Chloride (NaCl) 0.9 %. Primary outcome measures: 28-day mortality , 28 days after administration of the study intervention. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.