[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05537896":3,"trial-entities:NCT05537896":108,"trial-summary:NCT05537896":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":64,"minimum_age":65,"maximum_age":15,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":81,"locations":84,"central_contacts":100,"overall_officials":103,"references":106,"see_also_links":107},"NCT05537896","2206591296","Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia","Prospective Evaluation of Xerava™ (Eravacycline) Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia","RECRUITING","2028-02","2026-04","2026-04-16","2024-02-19","West Virginia University","OTHER",null,"Antibacterial prophylaxis is recommended in patients at high risk of infection, specifically patients undergoing acute leukemia induction therapy or hematopoietic stem cell transplant (HSCT) who are expected to have profound neutropenia (ANC\\\u003C100 neutrophils\u002Fmilliliter) for more than seven days. Xerava™ (eravacycline) has a broad spectrum of activity including many multi-drug resistant strains of bacteria. It is not an agent used for treatment of febrile neutropenia, making eravacycline a very attractive alternative to consider in this prophylactic setting. Eravacycline has activity against MRSA, VRE, and Clostridioides difficile, all of which are common problems in this patient population. It also covers the majority of enteric gram-negative pathogens while also producing satisfactory tissue penetration and adequate plasma concentrations, which has classically been a concern with prior agents. Eravacycline has activity against coagulase-negative staphylococcus, which is a common catheter-related infection in leukemia and HSCT patients. The primary objective will be report the incidence of breakthrough infections during eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.","Antibacterial prophylaxis is recommended in patients at high risk of infection, specifically patients undergoing acute leukemia induction therapy or hematopoietic stem cell transplant (HSCT) who are expected to have profound neutropenia (ANC\\\u003C100 neutrophils\u002Fmilliliter) for more than seven days.\n\nXerava™ (eravacycline) is a synthetic halogenated tetracycline class antibiotic, with a broad spectrum of activity including many multi-drug resistant strains of bacteria. It is not an agent used for treatment of febrile neutropenia, making eravacycline a very attractive alternative to consider in this prophylactic setting. Adverse effects with this agent are minimal including infusion site reactions and gastrointestinal disorders. Eravacycline has activity against MRSA, VRE, and Clostridioides difficile, all of which are common problems in this patient population. It also covers the majority of enteric gram-negative pathogens while also producing satisfactory tissue penetration and adequate plasma concentrations, which has classically been a concern with prior agents. Eravacycline has activity against coagulase-negative staphylococcus, which is a common catheter-related infection in leukemia and HSCT patients. The primary objective will be report the incidence of breakthrough infections during eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.",[19,20],"Hematological Malignancy","Neutropenia",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},55,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Eravacycline","Eravacycline will be continued until one of the following criteria is met:\n\n* neutrophil recovery (ANC \\>500, post-nadir)\n* febrile neutropenia\n* breakthrough infection\n* any grade 3-4 toxicity related to eravacycline use\n* 21 days of therapy (maximum duration allowed per study protocol)",[32],[36],"Xerava",[38],{"measure":39,"description":40,"timeFrame":41},"Incidence of Documented Breakthrough Infections","Number of Incidences documented that subjects had a confirmed breakthrough infection.","Up to 21 days",[43,47,51,54,58,61],{"measure":44,"description":45,"timeFrame":46},"Adverse Events","Incidence of Adverse Events: CTCAE criteria. CTCAE stands for Common Terminology Criteria for Adverse Events; these criteria are also called \"common toxicity criteria.\" In CTCAE, an adverse event (AE) is defined as any abnormal clinical finding temporally associated with the use of a therapy for cancer; causality is not required. These criteria are used for the management of chemotherapy administration and dosing, and in clinical trials to provide standardization and consistency in the definition of treatment-related toxicity.","Daily during Eravacycline",{"measure":48,"description":49,"timeFrame":50},"Infection-related mortality","Incidence of Infection-related mortality. Infection-related mortality is defined as any death that occurred in the presence of clinical or microbiological documented infection","Up to 30 days",{"measure":52,"description":53,"timeFrame":50},"All-cause mortality","Incidence of All-cause mortality defined as any death occurring during the clinical trial period.",{"measure":55,"description":56,"timeFrame":57},"Acute GVHD","Incidence of Acute Graft vs Host Disease (GVHD). GVHD is a complication of a bone marrow or stem cell transplant in which cells from a donor attack the tissues of the recipient.","Up to 100 days",{"measure":59,"description":60,"timeFrame":41},"Neutropenic fever","Rate of neutropenic fever: Defined as development of febrile neutropenia (temperature \\>38.2 degrees C and ANC is \\\u003C500 cells\u002Fmm3).",{"measure":62,"description":63,"timeFrame":41},"Time to neutropenic fever","Time to development of febrile neutropenia (temperature \\>38.2 degrees C and ANC is \\\u003C500 cells\u002Fmm3).","ALL","18 Years",false,{"inclusion":68,"exclusion":72,"raw_text":80},[69,70,71],"All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT","Patient must provide informed consent.","Bilirubin ≤ 3 x the ULN and AST\u002FALT ≤ 5 x ULN",[73,74,75,76,77,78,79],"Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.","Urinary tract infection receiving active treatment","Acute pancreatitis (not necessary to work-up unless symptomatic)","History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline","Pseudomonas infection within 30 days prior to study enrollment","Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)","Pregnant or lactating women","Inclusion Criteria:\n\n* All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT\n* Patient must provide informed consent.\n* Bilirubin ≤ 3 x the ULN and AST\u002FALT ≤ 5 x ULN\n\nExclusion Criteria:\n\n* Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.\n* Urinary tract infection receiving active treatment\n* Acute pancreatitis (not necessary to work-up unless symptomatic)\n* History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline\n* Pseudomonas infection within 30 days prior to study enrollment\n* Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)\n* Pregnant or lactating women",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":97},"Aaron Cumpston","Morgantown","West Virginia","26506","United States",[92],{"name":93,"role":94,"phone":95,"email":96},"Aaron Cumpston, PharmD, BCOP","CONTACT","3045984000","cumpstona@wvumedicine.org",{"lat":98,"lon":99},39.62953,-79.9559,[101],{"name":93,"role":94,"phone":95,"phoneExt":102,"email":96},"73350",[104],{"name":93,"affiliation":13,"role":105},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":112},[110,111],"Acute Leukemia","Hematopoietic Cell Transplantation",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":15},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This study is an interventional study planning to enroll 55 participants. The phase of the study is not specified.","completed","Xerava Prophylaxis for Hematological Malignancy Patients with Prolonged Neutropenia","This study is looking at whether the antibiotic Eravacycline (brand name Xerava) can help prevent infections in people with blood cancers (hematological malignancy) who are undergoing chemotherapy or stem cell transplants. These treatments can lead to a low white blood cell count (neutropenia), making patients very vulnerable to infections. Eravacycline is being tested to see if it can reduce the number of serious infections that occur. You might be able to join if you are an adult receiving certain types of chemotherapy for acute leukemia or preparing for a stem cell transplant, and meet specific liver function requirements. The study aims to see how many breakthrough infections happen while patients are taking Eravacycline. The current recruitment status is unclear.","The primary endpoint, incidence of breakthrough infections, is measured for up to 21 days.",119,"You would receive Eravacycline for up to 21 days, or until your white blood cell count recovers, you develop a fever, get an infection, or experience significant side effects.","Not stated in the trial record.",[32]]