[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548556":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":51,"responsibleParty":77,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":74,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":74,"enrollmentInfo":89,"targetDuration":74,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":54,"whyStopped":74,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Instituto Nacional de Cancerologia de Mexico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ceftolozane\u002Ftazobactam","EXPERIMENTAL","Ceftozolane\u002Ftazobactam (C\u002FT) is a combination antibiotic with a new cephalosporin, structurally similar to ceftazidime, plus tazobactam. The FDA approved This known beta-lactamase inhibitor in 2018 to treat intra-abdominal and complicated urinary infections. In 2019, its indication was expanded to nosocomial pneumonia and those associated with mechanical ventilation. In Mexico, it was approved for marketing in June 2019. C\u002FT has broad-spectrum activity since it has action against ESBL-producing Enterobacteria and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens.",[13],"Drug: Ceftolozane\u002Ftazobactam",{"label":15,"type":16,"description":17,"interventionNames":18},"Piperacillin\u002Ftazobactam","ACTIVE_COMPARATOR","At our hospital, Piperacillin\u002Ftazobactam is the primary drug used as an empirical treatment in patients with severe neutropenia and fever, according to Clinical Practice Guidelines for the use of antimicrobial agents in neutropenic patients with cancer.",[19],"Drug: Piperacillin\u002Ftazobactam",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ceftolozane\u002Ftazobactam 1.5 g tid IV infusion for 1 hour during 5 to 7 days",[9],[26],"Zerbaxa",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Piperacillin\u002Ftazobactam 4.5 g qid IV infusion for 30 minutes during 5 to 7 days",[15],[31,32,33,34],"Tazocin","Pipertazo","Tazonam","Tazovak",[36],{"name":37,"affiliation":38,"role":39},"Patricia Cornejo-Juarez, M.D.,M.Sc.","Instituto Nacional de Cancerología, Mexico","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Diana Vilar Compte, M.D.,M.Sc.","CONTACT","+52 5628 0400","12110","diana_vilar@yahoo.com.mx",{"name":48,"role":43,"phone":44,"phoneExt":49,"email":50},"Patricia Volkow, M.D.","12120","pvolkowf@gmail.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Instituto Nacional de Cancerologia","RECRUITING","Mexico City","Tlalpan","14080","Mexico","MX",{"type":61,"coordinates":62},"Point",[63,64],-99.12766,19.42847,{"lat":64,"lon":63},[67,70,71,75],{"name":68,"role":43,"phone":69,"phoneExt":45,"email":46},"Diana Vilar Compte, M.D., M.Sc.","+52 56280400",{"name":48,"role":43,"phone":69,"phoneExt":49,"email":50},{"name":72,"role":73,"phone":74,"phoneExt":74,"email":74},"Beda D Islas-Muñoz, M.D., M.Sc","SUB_INVESTIGATOR",null,{"name":76,"role":73,"phone":74,"phoneExt":74,"email":74},"Pamela Alatorre-Fernández, M.D.",{"type":39,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"Patricia Cornejo Juarez","Principal Investigator","100548556","ceftolozanetazobactam-vs-piperacillintazobactam-for-the-treatment-of-bacteremia-in-hemato-oncological-patients-100548556",false,"NCT06422533","Ceftolozane\u002FTazobactam vs. Piperacillin\u002FTazobactam for the Treatment of Bacteremia in Hemato-oncological Patients","Ceftolozane\u002FTazobactam vs. Piperacillin\u002FTazobactam for the Treatment of Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hemato-oncological Patients With Severe Neutropenia and Fever: Non-inferiority Study","Inclusion Criteria:\n\n* All patients \\>18 years old\n* Diagnosis of any hematological malignancy\n* Severe neutropenia (polymorphonuclear \\\u003C500 cells\u002Fmm3)\n* Fever (≥38.3 degrees Celsius in one measure, or ≥38 degrees Celsius in at least two measures)\n* Median arterial pressure ≥65 mmHg on admission\n* A life expectancy ≥ 5 days\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Known hypersensitivity to cephalosporins or anaphylaxis with beta-lactams\n* Clinical signs related to hemodynamic instability\n* Concomitant use of another antibiotic with activity against Gram-negatives (except Trimethoprim\u002FSulfamethoxazole (TMP\u002FSMX) as prophylaxis for P. jirovecii\n* Patients with end-stage chronic renal failure (\\\u003C10 ml\u002Fmin by creatinine clearance-ACCr) or on renal replacement therapy.\n* Patients with grade IV mucositis","ALL","18 Years",{"count":90,"type":91},226,"ESTIMATED","INTERVENTIONAL",[94],"NA","Patients with hematological malignancies receive highly myelotoxic chemotherapy regimens that cause periods of severe myelosuppression, which places them at high risk of developing bacteremia.\n\nAt a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR P.aeruginosa, have been described during the last decade. Among the strategies to reduce bacterial resistance, ceftolozane\u002Ftazobactam (C\u002FT) as a \"carbapenem-sparing\" antibiotic has been proposed.\n\nC\u002FT has broad-spectrum activity since it has action against ESBL-producing Enterobacteriaceae and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens.\n\nAt the National Cancer Institute (in Spanish, Instituto Nacional de Cancerologia), Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia. Escherichia coli occupies the first place in 25% (41% ESBL), followed by Klebsiella spp. in 5.6% (11.2% ESBL) and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hematological malignancy patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin\u002Ftazobactam (P\u002FT). In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P\u002FT-resistant bacteria are identified, this is escalated to carbapenem.\n\nTherefore, it is proposed to compare the clinical and microbiological response in patients with hematological malignancies who present with severe neutropenia and fever and who present clinical data of bacteremia, with empirical treatment with C\u002FT vs. P\u002FT, trying to reduce the use of carbapenems in this group of patients.",[97,98],"Hematologic Neoplasms","Neutropenia",[100,101,102,103],"ceftolozane\u002Ftazobactam","piperacillin\u002Ftazobactam","neutropenia","hematologic neoplasms","2024-06-02",{"date":106,"type":107},"2024-06-04","ACTUAL",{"date":109,"type":107},"2023-11-07",{"date":111,"type":91},"2025-08-30",{"name":5,"class":6},1]