Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:27 AM
Study NCT ID:
NCT07398703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended vs. Intermittent Beta-Lactam Infusion in ICU Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2025-09-28', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality at 90 days from the date of randomization.', 'timeFrame': 'Baseline and 90 days'}], 'secondaryOutcomes': [{'measure': 'Clinical cure', 'timeFrame': 'Baseline and 16 days', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beta-lactam', 'Extended', 'Intermittent', 'infusion', 'Sepsis', 'Septic shock'], 'conditions': ['Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '23074313', 'type': 'BACKGROUND', 'citation': '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': '37176628', 'type': 'BACKGROUND', 'citation': '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': '3928249', 'type': 'BACKGROUND', 'citation': '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': '1244564', 'type': 'BACKGROUND', 'citation': 'Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.'}, {'pmid': '38051467', 'type': 'BACKGROUND', 'citation': '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': '37463564', 'type': 'BACKGROUND', 'citation': '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': '36592205', 'type': 'BACKGROUND', 'citation': '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': '36272277', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBeta-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.\n\nIn 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.\n\nExisting 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patient diagnosed with pneumonia and urinary tract infection at Critical care unit at Assiut University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged: 18 - 65\n* Patients admitted to critical care unit diagnosed with pneumonia or urinary tract infection with two of the following:\n\n 1. Temperature: over 38 degree celsius\n 2. Heart rate: over 100 beats per minute\n 3. Respiratory rate: over 20 breaths per minute\n 4. leucocyte count over than 12000 or less than 4000 microlitres or over 10% immature forms or bands\n* Patients with positive sputum or urine cultures\n\nExclusion Criteria:\n\n* Hypersensitivity to Beta-lactams\n* Pregnancy\n* Very low probability of survival using APAACHE II score \\> 34 points.\n* Immunodeficency or taking immunosuppressive medications\n* Acute or chronic renal failure with creatinine clearance less than 30 ml/min according to Cockcroft-Gault formula.'}, 'identificationModule': {'nctId': 'NCT07398703', 'briefTitle': 'Extended vs. Intermittent Beta-Lactam Infusion in ICU Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': '"The Impact of Beta-Lactam Infusion Strategy on Treatment Efficacy in Sepsis and Septic Shock : Extended vs. Intermittent Dosing in the ICU"', 'orgStudyIdInfo': {'id': 'Beta-Lactam Infusion in sepsis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Extended infusion of beta-lactam antibiotics', 'interventionNames': ['Drug: Extended beta-lactam antibiotics']}, {'label': 'Group B', 'description': 'Intermittent infusion of beta-lactam antibiotics', 'interventionNames': ['Drug: Intermittent Beta-lactam antibiotics']}], 'interventions': [{'name': 'Extended beta-lactam antibiotics', 'type': 'DRUG', 'description': 'Group A will be receiving extended infusion of beta-lactam antibiotic over 4 hours.', 'armGroupLabels': ['Group A']}, {'name': 'Intermittent Beta-lactam antibiotics', 'type': 'DRUG', 'description': 'Group B will be receiving intermittent infusion of beta-lactam antibiotic over 30 minutes.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa Y.S. Sayed, MBBS', 'role': 'CONTACT', 'email': 'mostafa.yousef43@gmail.com', 'phone': '+201015479784'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician', 'investigatorFullName': 'Mostafa Yousif Sadik Sayed', 'investigatorAffiliation': 'Assiut University'}}}}