[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655916":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":30,"overallOfficials":30,"centralContacts":42,"locations":48,"responsibleParty":68,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":30,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":30,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":96,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"King Faisal Specialist Hospital & Research Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"To assess the incidence of developing true nephrotoxicity in patients receiving vancomycin + piperacillin-tazobactam versus vancomycin + meropenem.","True nephrotoxicity is defined as both serum creatinine and cystatin-C meet the AKI criteria on 2026 KDIGO criteria.\n\nSerum creatinine-based AKI: defined as any of the following: Change in SCr≥0.3 mg\u002FdL within 48 hours OR SCr≥1.5×baseline within 7 days.\n\nCystatin-C-Based AKI is defined as any of the following: ≥50% increase from baseline cystatin-C OR absolute increase ≥0.3 mg\u002FL from baseline","From enrollment until 72 hours from stopping vancomycin therapy",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Difference in time to AKI onset based on serum creatinine and cystatin C between the two groups","Time to AKI onset will be determined independently according to serum creatinine-based and cystatin C-based AKI criteria.\n\nTime to AKI onset will be calculated from initiation of the study antibiotic regimen to the first time the participant meets the respective AKI criterion. The difference in time to AKI onset between serum creatinine-based and cystatin C-based assessments will be evaluated and compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.","From enrollment until 72 hours from stopping vancomycin",{"measure":19,"description":20,"timeFrame":21},"Incidence of Transient and Persistent Acute Kidney Injury According to the 2026 KDIGO Criteria between the two study groups","AKI will be classified as transient or persistent according to the 2026 KDIGO AKI\u002FAKD criteria based on the duration of increased serum creatinine or cystatin C, or reduced urine output. The incidence of transient and persistent AKI will be compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.","From enrollment until 72 hours from vancomycin therapy cessation",{"measure":23,"description":24,"timeFrame":25},"Recovery from AKI according to the 2026 KDIGO Criteria","Recovery from AKI will be assessed according to the 2026 KDIGO AKI\u002FAKD criteria using serum creatinine-based and cystatin C-based assessments. The proportion of participants achieving recovery from AKI will be determined and compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.","From AKI onset through 90 days after AKI onset.",{"measure":27,"description":28,"timeFrame":29},"Severity of AKI staged according to the 2026 KDIGO criteria between the two groups","The severity of acute kidney injury (AKI) will be assessed according to the 2026 Kidney Disease: Improving Global Outcomes (KDIGO) AKI\u002FAKD criteria. Participants who develop AKI will be classified according to AKI severity (Stage 1, Stage 2, or Stage 3) based on serum creatinine and urine output criteria. The distribution of AKI severity stages will be compared between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem.","From AKI onset through 7 days after AKI onset.",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":6,"timePerspective":32,"maskingInfo":30},"PROSPECTIVE","Vancomycin is commonly administered in combination with broad-spectrum beta-lactam antibiotics for empiric treatment of serious infections. Several studies have reported a higher incidence of nephrotoxicity in patients receiving vancomycin plus piperacillin-tazobactam compared with vancomycin combined with other antipseudomonal beta-lactams. However, most of these studies have defined kidney injury using serum creatinine alone. This has raised concern that the observed increase in nephrotoxicity may, at least in part, represent pseudo-nephrotoxicity caused by an increase in serum creatinine without a corresponding reduction in true kidney function.\n\nThis prospective, non-interventional, comparative two-arm cohort study will evaluate adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem. Treatment selection, antimicrobial dosing, vancomycin therapeutic drug monitoring, fluid management, hemodynamic management, and other clinical decisions will remain under the responsibility of the treating clinical team and will not be determined by the study investigators.\n\nThe primary objective is to compare the incidence of true nephrotoxicity between the two treatment groups. Kidney function will be assessed prospectively using both serum creatinine and cystatin C. True nephrotoxicity will be defined as fulfillment of the study criteria for acute kidney injury using both serum creatinine and cystatin C, whereas pseudo-nephrotoxicity will be defined as serum creatinine-based acute kidney injury without a corresponding increase in cystatin C.\n\nSerum creatinine and cystatin C will be assessed at baseline and serially during combination antimicrobial therapy, with additional follow-up measurements after discontinuation when available according to the study protocol. This simultaneous biomarker assessment is intended to help distinguish functional changes in serum creatinine from kidney injury supported by a parallel change in cystatin C.\n\nSecondary assessments will include the time to onset of acute kidney injury based separately on serum creatinine and cystatin C, the incidence of transient and persistent acute kidney injury, kidney recovery, and the severity of acute kidney injury. Kidney recovery and progression to acute kidney disease will also be assessed during follow-up when applicable.\n\nPatients will be categorized into two observational exposure groups according to the beta-lactam prescribed by the treating team: vancomycin plus piperacillin-tazobactam or vancomycin plus meropenem. Relevant demographic, clinical, laboratory, antimicrobial exposure, and potential nephrotoxic risk factors will be prospectively collected.\n\nThe study is designed to clarify whether the higher incidence of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represents true renal injury or predominantly a serum creatinine-based phenomenon. The findings may improve interpretation of kidney function during antibiotic therapy and may help clinicians balance antimicrobial coverage with the risk of nephrotoxicity when selecting empiric antibiotic regimens.","Patients admitted to King Faisal Specialist Hospital and Research Center, and received vancomycin combined with either piperacillin-tazobactam or meropenem from August 2026 until achieving the pre-specified sample size will be screened for the inclusion and exclusion criteria",[36,39],{"label":37,"type":30,"description":38,"interventionNames":30},"Vancomycin - Piperacillin Tazobactam","Patients who will be receiving a combination of vancomycin and piperacillin-tazobactam for treating various types of infections",{"label":40,"type":30,"description":41,"interventionNames":30},"Vancomycin - Meropenem","Patients who will be receiving a combination of vancomycin and meropenem for treating various types of infections",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Hakeam A Hakeam, MS Pharm., BCPS","CONTACT","+966505494897","hakeam@kfshrc.edu.sa",[49],{"facility":50,"status":30,"city":51,"state":30,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"King Faisal Specialist Hospital and Research Center-Riyadh","Riyadh","11211","Saudi Arabia","SA",{"type":56,"coordinates":57},"Point",[58,59],46.72185,24.68773,{"lat":59,"lon":58},[62,66],{"name":63,"role":45,"phone":64,"phoneExt":65,"email":47},"Hakeam Hakeam, MS Pharm","+9664647272","38611",{"name":67,"role":45,"phone":30,"phoneExt":30,"email":30},"A",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Hakeam Abdulaziz Hakeam","Clinical Pharmacy Consultant","100655916","differentiating-true-nephrotoxicity-from-pseudo-nephrotoxicity-a-prospective-comparative-study-of-vancomycin-plus-piperacillin-tazobactam-vs-meropenem-using-serum-creatinine-and-cystatin-c-100655916",false,"NCT07818265","Differentiating True Nephrotoxicity From Pseudo-nephrotoxicity: A Prospective Comparative Study of Vancomycin Plus Piperacillin-Tazobactam vs. Meropenem Using Serum Creatinine and Cystatin-C","Inclusion Criteria:\n\n* Age ≥18 years.\n* Receipt of vancomycin in combination with either piperacillin-tazobactam or meropenem, with both antimicrobial agents prescribed by the treating physician and expected to be administered concomitantly for \\>48 hours.\n\nExclusion Criteria:\n\n* Known advanced chronic kidney disease (CKD), defined as a baseline estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m², or dialysis dependence..\n* Pregnancy.\n* Receipt of renal replacement therapy prior to enrollment.\n* Obstructive uropathy causing AKI.\n* Recipients of solid organ transplant or hematopoietic stem cell transplantation within one year of presentation\n* Concomitant receive of agents known to be nephrotoxins:\n\nAmphotericin B Aminoglycosides Calcineurin inhibitors\n\n* Patients with AKI 30 days prior to vancomycin initiation\n* Admission to the ICU for indication other than postoperative care for \\> 72 hours\n* Receiving vancomycin therapy within 30 days before the index combination","ALL","18 Years",{"count":81,"type":82},304,"ESTIMATED","OBSERVATIONAL","This prospective comparative observational study will compare the incidence of true nephrotoxicity in adult patients receiving vancomycin in combination with either piperacillin-tazobactam or meropenem.\n\nVancomycin plus piperacillin-tazobactam has been associated with a higher incidence of kidney injury based mainly on increases in serum creatinine. However, it remains uncertain whether these increases represent true kidney injury or pseudo-nephrotoxicity, in which serum creatinine increases without a corresponding decline in kidney function.\n\nTo address this uncertainty, the study will prospectively assess kidney function using both serum creatinine and cystatin C. True nephrotoxicity will be identified when changes in both biomarkers meet the study criteria for acute kidney injury, while an increase in serum creatinine without a corresponding cystatin C increase will be considered pseudo-nephrotoxicity.\n\nThe study will compare true nephrotoxicity between patients receiving vancomycin plus piperacillin-tazobactam and those receiving vancomycin plus meropenem. It will also evaluate the timing, persistence, severity, and recovery of kidney injury. The results may help clarify whether the higher rates of nephrotoxicity reported with vancomycin plus piperacillin-tazobactam represent true renal injury and may help guide antibiotic selection when balancing antimicrobial coverage and kidney safety.",[86,87,88,89],"Nephrotoxicity","Bacterial Infections","Acute Kidney Injury","Renal Impairment",[91,86,92,93,94,95],"Piperacillin tazobactam","Vancomycin","Meropenem","Cystatin-c","serum creatinine","NOT_YET_RECRUITING","2026-09-07",{"date":99,"type":100},"2026-09-14","ACTUAL",{"date":102,"type":82},"2026-09-15",{"date":104,"type":82},"2027-07-09",{"name":5,"class":6},1]