[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582536":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":10,"responsibleParty":30,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":10,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":10,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Avibactam sodium\u002FCeftazidime hydrate",null,"Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL\u002Fmin) who are administrated with Zavicefta (Avibactam sodium\u002FCeftazidime hydrate) for the first time",[13],"Drug: Avibactam sodium\u002FCeftazidime hydrate",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The recommended adult dosage is 2.5 g (0.5 g of avibactam and 2 g of ceftazidime) administered by intravenous infusion over a period of 2 hours 3 times daily. For peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess, Zavicefta should be co-administered with a metronidazole injection.",[9],[20],"Zavicefta",[22],{"name":23,"affiliation":5,"role":24},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100582536","a-study-to-learn-about-the-study-medicine---zavicefta-in-patients-with-sepsis-or-loss-of-kidney-function-in-japan-100582536",false,"NCT06864585","A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan","Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL\u002FMin) -","Inclusion Criteria:\n\n1. Patients who received Zavicefta for the first time after the launch of Zavicefta\n2. Patients who received Zavicefta for an infectious diseases indicated for Zavicefta\n3. Patients with diagnosis of sepsis and\u002For renal impairment (creatinine clearance ≤ 50mL\u002Fmin) at the start of the treatment with Zavicefta\n4. Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use\n\nExclusion Criteria:\n\nThere are no exclusion criteria for this study.","ALL","0 Years",{"count":42,"type":43},59,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.\n\nZavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.\n\nThis study is seeking for patients with:\n\n* sepsis (A very serious infection in your blood caused by germ (a bacteria)) or\n* renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.\n\nSubjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.",[47],"Infectious Diseases",[49],"Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime","NOT_YET_RECRUITING","2026-04-17",{"date":53,"type":54},"2026-04-20","ACTUAL",{"date":56,"type":43},"2026-09-15",{"date":58,"type":43},"2029-03-30",{"name":5,"class":6}]