Extended vs. Intermittent Beta-Lactam Infusion in ICU Sepsis

NCT07398703 | Not Yet Recruiting

• 1 other identifier: Beta-Lactam Infusion in sepsis
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Septic Shock

Keywords

Beta-lactam; Extended; Intermittent; infusion; Sepsis; Septic shock

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 90 days from the date of randomization.

  Baseline and 90 days

Secondary Outcomes (1)

• Clinical cure

  Baseline and 16 days

Study Arms (2)

Group A

Extended infusion of beta-lactam antibiotics

Drug: Extended beta-lactam antibiotics

Group B

Intermittent infusion of beta-lactam antibiotics

Drug: Intermittent Beta-lactam antibiotics

Interventions

Extended beta-lactam antibiotics DRUG

Group A will be receiving extended infusion of beta-lactam antibiotic over 4 hours.

Group A

Intermittent Beta-lactam antibiotics DRUG

Group B will be receiving intermittent infusion of beta-lactam antibiotic over 30 minutes.

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Aged: 18 - 65
• Patients admitted to critical care unit diagnosed with pneumonia or urinary tract infection with two of the following:
• Temperature: over 38 degree celsius
• Heart rate: over 100 beats per minute
• Respiratory rate: over 20 breaths per minute
• leucocyte count over than 12000 or less than 4000 microlitres or over 10% immature forms or bands
• Patients with positive sputum or urine cultures

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Dulhunty JM, Roberts JA, Davis JS, Webb SA, Bellomo R, Gomersall C, Shirwadkar C, Eastwood GM, Myburgh J, Paterson DL, Lipman J. Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicenter double-blind, randomized controlled trial. Clin Infect Dis. 2013 Jan;56(2):236-44. doi: 10.1093/cid/cis856. Epub 2012 Oct 16.

  PMID: 23074313 BACKGROUND

• Guarino M, Perna B, Cesaro AE, Maritati M, Spampinato MD, Contini C, De Giorgio R. 2023 Update on Sepsis and Septic Shock in Adult Patients: Management in the Emergency Department. J Clin Med. 2023 Apr 28;12(9):3188. doi: 10.3390/jcm12093188.

  PMID: 37176628 BACKGROUND

• Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

  PMID: 3928249 BACKGROUND

• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

  PMID: 1244564 BACKGROUND

• Li X, Long Y, Wu G, Li R, Zhou M, He A, Jiang Z. Prolonged vs intermittent intravenous infusion of beta-lactam antibiotics for patients with sepsis: a systematic review of randomized clinical trials with meta-analysis and trial sequential analysis. Ann Intensive Care. 2023 Dec 5;13(1):121. doi: 10.1186/s13613-023-01222-w.

  PMID: 38051467 BACKGROUND

• Tamma PD, Aitken SL, Bonomo RA, Mathers AJ, van Duin D, Clancy CJ. Infectious Diseases Society of America 2023 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections. Clin Infect Dis. 2023 Jul 18:ciad428. doi: 10.1093/cid/ciad428. Online ahead of print.

  PMID: 37463564 BACKGROUND

• Povoa P, Coelho L, Dal-Pizzol F, Ferrer R, Huttner A, Conway Morris A, Nobre V, Ramirez P, Rouze A, Salluh J, Singer M, Sweeney DA, Torres A, Waterer G, Kalil AC. How to use biomarkers of infection or sepsis at the bedside: guide to clinicians. Intensive Care Med. 2023 Feb;49(2):142-153. doi: 10.1007/s00134-022-06956-y. Epub 2023 Jan 2.

  PMID: 36592205 BACKGROUND

• Mirjalili M, Zand F, Karimzadeh I, Masjedi M, Sabetian G, Mirzaei E, Vazin A. The clinical and paraclinical effectiveness of four-hour infusion vs. half-hour infusion of high-dose ampicillin-sulbactam in treatment of critically ill patients with sepsis or septic shock: An assessor-blinded randomized clinical trial. J Crit Care. 2023 Feb;73:154170. doi: 10.1016/j.jcrc.2022.154170. Epub 2022 Oct 19.

  PMID: 36272277 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Mostafa Y.S. Sayed, MBBS

CONTACT

+201015479784; mostafa.yousef43@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: February 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02