Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT03344627
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2017-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-09', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOFA score change', 'timeFrame': 'Change from Baseline SOFA score at day 4', 'description': 'The Sequential organ failure assessment (SOFA) score describe the time course of multiple organ dysfunction.\n\nThe SOFA score is composed of scores for six organ systems (respiratory, cardiovascular, neurological, hepatic, renal and coagulation).\n\nThe function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24.\n\nPrimary outcome is assessing change between SOFA score at baseline and SOFA score at day 4 after treatment by meropenem'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '14 and 28 days', 'description': 'In hospital mortality'}, {'measure': 'Clinical cure', 'timeFrame': 'Day 3, 5, 7, 10 and 14', 'description': 'Composite of:\n\n1. Persistent fever and/or\n2. Stable or increased white blood cell count'}, {'measure': 'Microbiological cure', 'timeFrame': 'Day 3, 5, 7, 10 and 14', 'description': 'Elimination of the study entry pathogen within 14 days after received meropenem\n\n* Bacteremia: no growth in blood cultures\n* Intra-abdominal infection: no growth in blood cultures\n* UTI: uropathogen growth of less than 10\\^4 CFU/mL in women or less than 10\\^3 CFU/mL in men\n* HAP/VAP: pathogen in sputum culture growth of less than 10\\^3 CFU/mL\n* SSTI: no growth in blood cultures'}, {'measure': 'Duration of vasopressor agents', 'timeFrame': '14 and 28 days', 'description': 'Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation'}, {'measure': 'Duration of mechanical ventilator', 'timeFrame': '14 and 28 days', 'description': 'Time interval (day) of mechanical ventilator'}, {'measure': 'Length of ICU stay', 'timeFrame': '14 and 28 days', 'description': 'Time interval (day) from ICU admission (after randomization) to ICU discharge'}, {'measure': 'Length of hospital stay', 'timeFrame': '14 and 28 days', 'description': 'Time interval (day) from hospital admission (after randomization) to hospital discharge'}, {'measure': '%T > MIC', 'timeFrame': 'Day 1', 'description': '% time of meropenem concentration above MIC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Septic Shock', 'Critical Illness', 'Carbapenem', 'Pharmacokinetic', 'Pharmacodynamic', 'Clinical Outcome', 'Organ Failure, Multiple', 'Morality']}, 'referencesModule': {'references': [{'pmid': '25753628', 'type': 'BACKGROUND', 'citation': 'Jaruratanasirikul S, Thengyai S, Wongpoowarak W, Wattanavijitkul T, Tangkitwanitjaroen K, Sukarnjanaset W, Jullangkoon M, Samaeng M. Population pharmacokinetics and Monte Carlo dosing simulations of meropenem during the early phase of severe sepsis and septic shock in critically ill patients in intensive care units. Antimicrob Agents Chemother. 2015;59(6):2995-3001. doi: 10.1128/AAC.04166-14. Epub 2015 Mar 9.'}, {'pmid': '28098629', 'type': 'BACKGROUND', 'citation': 'Roberts JA, Kumar A, Lipman J. Right Dose, Right Now: Customized Drug Dosing in the Critically Ill. Crit Care Med. 2017 Feb;45(2):331-336. doi: 10.1097/CCM.0000000000002210.'}, {'pmid': '27148448', 'type': 'BACKGROUND', 'citation': 'Suwantarat N, Carroll KC. Epidemiology and molecular characterization of multidrug-resistant Gram-negative bacteria in Southeast Asia. Antimicrob Resist Infect Control. 2016 May 4;5:15. doi: 10.1186/s13756-016-0115-6. eCollection 2016.'}, {'pmid': '25038549', 'type': 'BACKGROUND', 'citation': 'Blot SI, Pea F, Lipman J. The effect of pathophysiology on pharmacokinetics in the critically ill patient--concepts appraised by the example of antimicrobial agents. Adv Drug Deliv Rev. 2014 Nov 20;77:3-11. doi: 10.1016/j.addr.2014.07.006. Epub 2014 Jul 15.'}, {'pmid': '25888181', 'type': 'BACKGROUND', 'citation': 'Marquet K, Liesenborgs A, Bergs J, Vleugels A, Claes N. Incidence and outcome of inappropriate in-hospital empiric antibiotics for severe infection: a systematic review and meta-analysis. Crit Care. 2015 Feb 16;19(1):63. doi: 10.1186/s13054-015-0795-y.'}, {'pmid': '7648757', 'type': 'BACKGROUND', 'citation': 'Mouton JW, van den Anker JN. Meropenem clinical pharmacokinetics. Clin Pharmacokinet. 1995 Apr;28(4):275-86. doi: 10.2165/00003088-199528040-00002.'}, {'pmid': '28231816', 'type': 'BACKGROUND', 'citation': 'de Grooth HJ, Geenen IL, Girbes AR, Vincent JL, Parienti JJ, Oudemans-van Straaten HM. SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis. Crit Care. 2017 Feb 24;21(1):38. doi: 10.1186/s13054-017-1609-1.'}, {'pmid': '32318268', 'type': 'DERIVED', 'citation': 'Lertwattanachai T, Montakantikul P, Tangsujaritvijit V, Sanguanwit P, Sueajai J, Auparakkitanon S, Dilokpattanamongkol P. Clinical outcomes of empirical high-dose meropenem in critically ill patients with sepsis and septic shock: a randomized controlled trial. J Intensive Care. 2020 Apr 15;8:26. doi: 10.1186/s40560-020-00442-7. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years and older) with sepsis and/or septic shock according to SEPSIS-3 criteria and receive meropenem within 1 hour after diagnosis\n* Informed consent signed by patient or their legally authorized representative\n\nExclusion Criteria:\n\n* Subjects with infective endocarditis\n* Subjects with central nervous system infection\n* Subjects who requires surgical condition within 72 hours after randomization\n* Subjects on extracorporeal membrane oxygenation (ECMO) within 3 days after randomization\n* Subjects with active seizure\n* History of receiving meropenem within 1 week prior to randomization\n* Pregnancy women and lactation\n* Known allergy to meropenem\n* Not complete a 72-hour course of empirical meropenem treatment'}, 'identificationModule': {'nctId': 'NCT03344627', 'briefTitle': 'Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients', 'orgStudyIdInfo': {'id': 'ID07-60-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Meropenem standard dose', 'description': 'Meropenem 1 g every 8 hours', 'interventionNames': ['Drug: Meropenem standard dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meropenem high dose', 'description': 'Meropenem 2 g every 8 hours', 'interventionNames': ['Drug: Meropenem high dose']}], 'interventions': [{'name': 'Meropenem standard dose', 'type': 'DRUG', 'description': '* Empirical with 1 g meropenem intravenous infusion in 30 minutes then 1 g intravenous infusion in 3 hours every 8 hours.\n* Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection.', 'armGroupLabels': ['Meropenem standard dose']}, {'name': 'Meropenem high dose', 'type': 'DRUG', 'description': '* Empirical with 2 g meropenem intravenous infusion in 30 minutes then 2 g intravenous infusion in 3 hours every 8 hours.\n* Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection', 'armGroupLabels': ['Meropenem high dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Ramathibodi Hospital', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'overallOfficials': [{'name': 'Tospon Lertwattanachai, B.sc.(Pharm)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tospon Lertwattanachai', 'investigatorAffiliation': 'Mahidol University'}}}}