CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 398 enrolled
Drug / intervention
Ceftriaxone +3 moredrug
Likely dose
Ceftriaxone 2gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02473263
NCT02473263Phase 3Completed
CompareCT.gov

Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock

Assistance Publique - Hôpitaux de Paris·interventional·Posted Jun 16, 2015·Updated Nov 20, 2025

In Brief

A Phase 3 clinical trial evaluating Ceftriaxone, Piperacillin tazobactam, and 2 other interventions for Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit. Completed, enrolled 398 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether an aggressive strategy of severe sepsis patients since pre hospital care, including early antibiotics administration, hemodynamic optimization, and opotherapy when indicated, could reduce mortality

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit
CountriesFrance
CollaboratorsURC-CIC Paris Descartes Necker Cochin

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 16, 2015
Enrollment StartMay 9, 2016
Primary CompletionFeb 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.0 years ago

Interventions

Ceftriaxonedrug

Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome

Piperacillin tazobactamdrug

Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome

Norepinephrinedrug

Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading

Hydrocortisonedrug

Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h