Extended vs. Intermittent Beta-Lactam Infusion in ICU Sepsis

February 2, 2026 updated by: Mostafa Yousif Sadik Sayed, Assiut University

"The Impact of Beta-Lactam Infusion Strategy on Treatment Efficacy in Sepsis and Septic Shock : Extended vs. Intermittent Dosing in the ICU"

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock should be considered a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities significantly increase mortality risk compared to sepsis alone.

Beta-lactam antibiotics exhibit broad-spectrum activity against most Gram-positive and Gram-negative bacteria, making them a key component of sepsis treatment. Their bactericidal effects are time-dependent, meaning efficacy depends on maintaining free drug concentrations above the minimum inhibitory concentration of the target pathogen for an optimal duration.

In clinical practice, beta-lactams are typically administered via intermittent infusion. However, critically ill patients often experience altered pharmacokinetics due to changes in renal clearance, protein binding, fluid balance, and volume distribution. This variability can lead to unpredictable drug concentrations, increasing the risk of subtherapeutic antibiotic exposure.

Existing studies suggest that continuous infusion may enhance beta-lactam efficacy by maintaining drug concentrations above the minimum inhibitory concentration for longer periods, optimizing pharmacokinetic and pharmacodynamic targets. Some meta-analyses and small randomized controlled trials report reduced mortality and improved clinical cure rates with continuous infusion, while others show no significant difference. However, differences in dosing regimens, patient populations, and pharmacokinetic variability in critically ill patients make it difficult to draw firm conclusions.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill patient diagnosed with pneumonia and urinary tract infection at Critical care unit at Assiut University Hospital

Description

Inclusion Criteria:

  • Aged: 18 - 65

  • Patients admitted to critical care unit diagnosed with pneumonia or urinary tract infection with two of the following:

    1. Temperature: over 38 degree celsius
    2. Heart rate: over 100 beats per minute
    3. Respiratory rate: over 20 breaths per minute
    4. leucocyte count over than 12000 or less than 4000 microlitres or over 10% immature forms or bands
  • Patients with positive sputum or urine cultures

Exclusion Criteria:

  • Hypersensitivity to Beta-lactams
  • Pregnancy
  • Very low probability of survival using APAACHE II score > 34 points.
  • Immunodeficency or taking immunosuppressive medications
  • Acute or chronic renal failure with creatinine clearance less than 30 ml/min according to Cockcroft-Gault formula.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Extended infusion of beta-lactam antibiotics
Drug: Extended beta-lactam antibiotics
Group A will be receiving extended infusion of beta-lactam antibiotic over 4 hours.
Group B
Intermittent infusion of beta-lactam antibiotics
Drug: Intermittent Beta-lactam antibiotics
Group B will be receiving intermittent infusion of beta-lactam antibiotic over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality at 90 days from the date of randomization.
Time Frame: Baseline and 90 days
Baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure
Time Frame: Baseline and 16 days
defined as completing the full course of beta-lactam therapy within 14 days without requiring additional antibiotics for the same infection within 48 hours after treatment cessation.
Baseline and 16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 28, 2025

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beta-Lactam Infusion in sepsis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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