MedTrace Logo

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis

NCT05681442 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-02-27

No results posted yet for this study

Summary

Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria). The study will be a prospective multicentre, randomized, open-label comparative continuous vs. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design.

Conditions

Interventions

DRUG

continuous pivotal βL-AB

continuous pivotal βL-AB

DRUG

intermittent pivotal βL-AB

intermittent pivotal βL-AB (IID = control group)

DRUG

AG infusion most 1 dose

AG infusion most 1 dose (AMT group )

DRUG

AG infusion for 5 days

AG infusion for 5 days (ACT Group)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Aline DECHANET · Assistance Publique - Hôpitaux de Paris (AP-HP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2027-01-04
Completion
2027-06-04

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681442 on ClinicalTrials.gov