[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505516":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":39,"locations":47,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":18,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":18,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":100,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Phramongkutklao College of Medicine and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Dose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation",[13],"Drug: Dose-adjustment by PKPD",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Dose antibiotics from standard care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dose-adjustment by PKPD","Dose-adjustment by pharmacokinetic and pharmacodynamic using Monte Carlo simulation",[9],[26],"Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)",[28,32,35,37],{"name":29,"affiliation":30,"role":31},"Sujareenoot Suya, PharmD","Faculty of Pharmacy, Silpakorn University","STUDY_CHAIR",{"name":33,"affiliation":30,"role":34},"Weerayuth Saelim, BCP","STUDY_DIRECTOR",{"name":36,"affiliation":30,"role":34},"Wichai Santimaleeworagun, PhD",{"name":38,"affiliation":5,"role":34},"Worapong Nasomsong, MD",[40,44],{"name":29,"role":41,"phone":42,"phoneExt":18,"email":43},"CONTACT","66814738170","Auensujareenoot@gmail.com",{"name":33,"role":41,"phone":45,"phoneExt":18,"email":46},"66891705954","Saelim_w6@su.ac.th",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Phramongkutklao Hospital","RECRUITING","Ratchathewi","Bangkok","10400","Thailand","TH",{"type":57,"coordinates":58},"Point",[59,60],100.53358,13.759,{"lat":60,"lon":59},[63,64,65,67,68,70],{"name":29,"role":41,"phone":42,"phoneExt":18,"email":43},{"name":33,"role":41,"phone":45,"phoneExt":18,"email":46},{"name":29,"role":66,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":33,"role":66,"phone":18,"phoneExt":18,"email":18},{"name":36,"role":69,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":38,"role":69,"phone":18,"phoneExt":18,"email":18},{"type":72,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[74],{"name":75,"class":6},"Silpakorn University","100505516","phase-4-dose-optimization-by-pharmacokineticpharmacodynamic-of-antibiotics-to-improve-clinical-outcome-of-carbapenem-resistant-klebsiella-pneumoniae-bloodstream-infections-in-critically-ill-patients-at-phramongkutklao-hospital-100505516",false,"NCT05862402","Dose Optimization by Pharmacokinetic\u002FPharmacodynamic of Antibiotics to Improve Clinical Outcome of Carbapenem Resistant Klebsiella Pneumoniae Bloodstream Infections in Critically Ill Patients at Phramongkutklao Hospital","Dose Optimization by PK\u002FPD of Antibiotics to Improve Clinical Outcome of CRKP Bloodstream Infections in Critically Ill Patients and in Vitro Study of Monotherapy, Combination Therapy and Molecular Biology of Drug Resistance at Phramongkutklao Hospital: Prospective, Historical Controlled Study","Inclusion Criteria:\n\n1. 20 years and older who admitted at Phramongkutklao Hospital\n2. Patients who was diagnosed blood stream infection with CRKP between April 10th, 2023 to March 31st, 2024 (Prospective study) and January 1st, 2012 to March 31st, 2023 (Retrospective study); Historical group\n3. Patients who had signs and symptoms at least 1 criteria following:\n\n   3.1. Patients who had signs and symptoms of Systemic Inflammatory Response Syndrome (SIRS) at least 2 criteria:\n   * Temperature above 38 oC or below 36 oC\n   * Heart rate more than 90 beats\u002Fmin\n   * Respiratory rate more than 20 \u002Fmin or PaCO2 less than 32 mmHg (4.3 kPa)\n   * White blood cell more than 12,000 cell\u002Fmm3 or less than 4,000 cell\u002Fmm3 3.2. Patients who was diagnosed sepsis or SOFA score or qSOFA score at least 2 score 3.3. Patients who was diagnosed septic shock or who had hypotension with adequate fluid and need for vasopressor to maintain mean arterial pressure over 65 mmHg and serum lactate above 2 mmol\u002FL\n4. Patients who received antibiotics at least 48 hours which are as follow:\n\n   * Ceftazidime-Avibactam or\n   * Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline- Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)\n\nExclusion Criteria:\n\n1. Patients who were pregnancy or breastfeeding\n2. Patients who had drug allergy (eg. Ceftazidime-Avibactam, Tigecycline, Amikacin, Gentamicin, Imipenem, Meropenem or Colistin)\n3. Patients who not to received resuscitation.\n4. Patients who were end stage cancer.","ALL","20 Years",{"count":86,"type":87},76,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","The patients who infected with Carbapenem resistant Klebsiella pneumoniae were high mortality rate. Appropriate antibiotics therapy adjusted by Pharmacokinetic\u002FPharmacodynamic plays an important role in determining outcomes in Critically ill patients. Consequently, standard antibiotics dose may not be adequate to achieve pharmacokinetic\u002Fpharmacodynamic target in Critically ill patients. The purpose of this study is to compare the clinical outcomes between the critically ill patients who received antibiotics dose adjusted by pharmacokinetic\u002Fpharmacodynamic using Monte Carlo simulation and historical critically ill patients who received antibiotics from standard practice.",[93],"Carbapenem Resistant Klebsiella Pneumoniae",[95,96,97,98,99],"Antibiotics","Dose optimization","Clinical outcome","CRKP","Critically ill","UNKNOWN","2023-05-07",{"date":103,"type":104},"2023-05-17","ACTUAL",{"date":101,"type":87},{"date":107,"type":87},"2024-06-30",{"name":5,"class":6},1]