Septic Shock / Extended beta-lactam antibiotics / Intermittent Beta-lactam antibiotics · Observational Study

Extended vs. Intermittent Meropenem Infusion in Sepsis Patients in the ICU

ClinicalTrials.gov · September 1, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational study comparing extended versus intermittent beta-lactam infusion in sepsis patients, with 28-day all-cause mortality as the primary outcome. No results have been posted to the registry, and recruitment has not yet begun.

What was studied

Observational. Sepsis, Septic Shock; age from 18 Years; to 65 Years. Intervention: Group A; Group B. Compared with: Intermittent beta-lactam antibiotics. n = 90.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned observational study with no reported results; enrollment has not yet begun, making it an early-stage descriptive protocol.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: All-cause mortality at 28 days from the date of randomization. (assessed at Baseline and 28 days)

DesignObservational

PopulationSepsis, Septic Shock; age from 18 Years; to 65 Years

Sample size90

InterventionGroup A; Group B

ComparatorIntermittent beta-lactam antibiotics

Reported figures

Quoted from the source exactly as published.

Planned enrollment90

Primary outcome measureAll-cause mortality at 28 days from the date of randomization

Caveats

This is a registry record only; no results have been posted and recruitment has not yet begun.
No sample size justification, power calculation, or statistical analysis plan is described.
The registry states 'observational' but mentions 'randomization' in the outcome measure; the actual allocation method is unclear.
Secondary outcomes and secondary endpoint measures are not provided in the source text.

Evidence assessment

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.

Study design

limited

Observational design without randomization or blinding described.

Directness

strong

Directly addresses mortality in sepsis patients; 28-day all-cause mortality is clinically relevant.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry alone.

Risk of bias

insufficient

Registry does not describe allocation concealment, blinding, or other bias mitigation.

Sample adequacy

moderate

Planned enrollment 90 participants; adequacy depends on outcome frequency not yet known.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07398703). This is a study registration, not published results. Lead sponsor: Assiut University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Sepsis, Septic Shock. Interventions: DRUG: Extended beta-lactam antibiotics; DRUG: Intermittent Beta-lactam antibiotics. Primary outcome measures: All-cause mortality at 28 days from the date of randomization. , Baseline and 28 days. Brief summary: This observational study compares extended versus intermittent beta-lactam infusion in sepsis patients, assessing survival, clinical cure rates, and practical ICU challenges. The findings will guide optimal antibiotic protocols, potentially improving sepsis outcomes through precision dosing strategies.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Septic ShockNCT07398703Assiut UniversityExtended beta-lactam antibioticsIntermittent Beta-lactam antibioticsSepsis