[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623597":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":34,"overallOfficials":11,"centralContacts":44,"locations":11,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":11,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":11},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause mortality at 28 days from the date of randomization.",null,"Baseline and 28 days",[14],{"measure":15,"description":16,"timeFrame":17},"Clinical cure","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",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":19,"timePerspective":20,"maskingInfo":11},"COHORT","PROSPECTIVE","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.","Critically ill patient diagnosed with pneumonia at Critical care unit at Assiut University Hospital",[24,29],{"label":25,"type":11,"description":26,"interventionNames":27},"Group A","Extended infusion of beta-lactam antibiotics",[28],"Drug: Extended beta-lactam antibiotics",{"label":30,"type":11,"description":31,"interventionNames":32},"Group B","Intermittent infusion of beta-lactam antibiotics",[33],"Drug: Intermittent Beta-lactam antibiotics",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","Extended beta-lactam antibiotics","Group A will be receiving extended infusion of beta-lactam antibiotic over 4 hours.",[25],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Intermittent Beta-lactam antibiotics","Group B will be receiving intermittent infusion of beta-lactam antibiotic over 30 minutes.",[30],[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Mostafa Y.S. Sayed, MBBS","CONTACT","+201015479784","mostafa.yousef43@gmail.com",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Mostafa Yousif Sadik Sayed","Resident physician","100623597","extended-vs-intermittent-beta-lactam-infusion-in-icu-sepsis-100623597",false,"NCT07398703","Extended vs. Intermittent Meropenem Infusion in Sepsis Patients in the ICU","\"The Impact of Meropenem Strategy on Treatment Efficacy in Sepsis and Septic Shock : Extended vs. Intermittent Dosing in the ICU\"","Inclusion Criteria:\n\n* Aged: 18 - 65\n* Patients admitted to critical care unit diagnosed with pneumonia 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\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\u002Fmin according to Cockcroft-Gault formula.","ALL","18 Years","65 Years",{"count":65,"type":66},90,"ESTIMATED","1 Day","OBSERVATIONAL","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.",[71,72],"Sepsis","Septic Shock",[74,75,76,71,77,78],"Extended","Intermittent","infusion","Septic shock","Meropenem","NOT_YET_RECRUITING","2026-08-28",{"date":82,"type":83},"2026-09-01","ACTUAL",{"date":85,"type":66},"2027-10",{"date":87,"type":66},"2028-04",{"name":5,"class":6}]