[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"catheter-related-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:catheter-related-infections":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,87,111,137,160,201,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100571024","phase-4-open-label-study-to-assess-safety-and-time-to-catheter-related-bloodstream-infections-crbsi-in-subjects-from-birth-to--18-years-of-age-100571024",false,"NCT06714864","Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to \u003C 18 Years of Age","An Open-Label, Two-Arm (DefenCath® vs. Institutional Standard of Care) Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to Less Than 18 Years of Age With Kidney Failure Receiving Hemodialysis Via a Central Venous Catheter","Inclusion Criteria:\n\n* All participants must be \\\u003C 18 years of age and must meet the following inclusion criteria:\n* The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.\n* A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the schedule of activities (SoA) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant during the scheduled study visits; accurately and reliably dispense study intervention as directed.\n* The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.\n* The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.\n* The participant has demonstrated the ability to achieve an appropriate minimum blood flow (Qb) for the participant's relative age and weight for at least 2 consecutive dialysis sessions to enable successful HD.\n* The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.\n* The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.\n* The participant is receiving adequate HD as assessed by the investigators and based on a single pool Kt\u002FV measurement \\> 1.2 (within the last 40 days).\n* The participant is not expected to expire within 180 days, based on clinical assessment.\n* Female participants of childbearing potential:\n* Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last administration of study treatment.\n* Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last administration of study treatment:\n* True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post ovulation methods\\] and withdrawal are not acceptable).\n\nCombined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.\n\n* Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.\n* Bilateral tubal occlusion\u002Fligation.\n* Intrauterine device.\n* Intrauterine hormone releasing system.\n* Vasectomized partner.\n* NOTE: If the childbearing potential changes after start of the study (e.g., a premenarchal female participant experiences menarche) or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception, or a male participant must use a condom. If reproductive status is questionable, additional evaluation should be considered.\n* Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male participant has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last administration of study treatment.\n\nExclusion Criteria:\n\n* The participant has received systemic antibiotics within the last 14 days. Topical antibiotic use is permitted.\n* Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.\n* The participant has received any thrombolytic treatment (i.e., tissue plasminogen activator \\[tPA\\] - Cathflo®), not as part of the institution's standard of care for patency management, in their current catheter within 30 days of randomization.\n* The fill volume of catheter lumen(s) is unknown or cannot be determined.\n* The participant uses any type of antimicrobial-coated or heparin-coated catheter.\n* Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.\n* Documented history of an atrial thrombus or known hypercoagulable state.\n* The participant has open, non-healing skin ulcers.\n* Current requirement for systemic immunosuppression that would increase risk of infection, such as:\n* High dose steroid. Low-dose steroids, such as routinely used for maintenance of organ transplants, are acceptable.\n* Methotrexate dose sufficiently high to suppress white blood cells (WBC) below 5,000 cells\u002FµL.\n* Biologic immunomodulators (anti-tumour necrosis factor, anti-CD4 antibody, etc.) within 30 days.\n* Azathioprine.\n* Calcineurin inhibitors (dose determined by investigator).\n* Sirolimus.\n* An active malignancy that either in and of itself or by virtue of its treatment with chemotherapy or biologic therapy results in neutropenia, leukopenia and\u002For immunosuppression.\n* Known allergy or absolute contraindication to taurolidine, citrate, or heparin, or a history of heparin induced thrombocytopenia (HIT).\n* Unstable malignancy.\n* Cirrhosis with encephalopathy.\n* The participant is currently taking another medication with known systemic drug interaction with taurolidine, citrate, or heparin.\n* The participant is anticipated to receive a renal transplant within 90 days (participants can be on the transplant list, but a participant with a known or anticipated transplant date within the next 90 days should be excluded).\n* The participant has a clinically significant cardiac rhythm or functional disorder.\n* The participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension prior to randomization based on assessment of the investigator.\n* Any other medical condition which renders the participant unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the participant.","ALL","17 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.",[26],"Catheter-Related Infections","RECRUITING","2026-05-15",{"date":30,"type":31},"2026-05-19","ACTUAL",{"date":33,"type":31},"2025-07-08",{"date":35,"type":20},"2029-04",{"name":37,"class":38},"CorMedix","INDUSTRY",6,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":64,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100594451","chlorhexidine-caps-for-clabsi-prevention-in-hemodialysis-a-pilot-randomized-controlled-trial-100594451","NCT07019610","Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial","Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial","ECHO-HD","Inclusion Criteria:\n\n* Age≥18\n* Able to provide informed consent\n* Kidney failure requiring a tunnelled CVC for treatment (haemodialysis)\n* 21 days BSI free\n* No known allergy to chlorhexidine and\u002For nylon and\u002For polypropylene.\n\nExclusion Criteria:\n\n* Current CLABSI\n* Known allergic to chlorhexidine and\u002For nylon and\u002For polypropylene.\n* Patients on an end-of-life pathway\n* People with a cognitive impairment and\u002For intellectual disability","18 Years",{"count":50,"type":20},60,[52],"NA","The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service.\n\nThe main questions to answer are:\n\n* Study Feasibility\n* Occurrence of infectious complications related to renal central venous catheters\n\nParticipants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub:\n\n* The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or\n* The intervention hemodialysis cap containing chlorhexidine inside it\n\nResearchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.",[55,56,57,58,59,26,60,61,62,63],"Vascular Access Complication","Device Related Infection","Device Related Sepsis","Catheter Infection","Catheter Complications","Catheter Related Complications","Hemodialysis Catheter Infection","Hemodialysis Catheter-associated Infection","Hemodialysis Complication",[65,66,67,68,69,70,71,72,73,74],"Hemodialysis Catheter","Randomised Controlled Trial","Antimicrobial Barrier Caps","Vascular access device","Hemodialysis catheter caps","Chlorhexidine cap","Central Venous Catheter","CVC","CLABSI","Central Line Associated Blood Stream Infection","NOT_YET_RECRUITING","2026-04-27",{"date":78,"type":31},"2026-04-29",{"date":80,"type":20},"2026-06",{"date":82,"type":20},"2028-02",{"name":84,"class":85},"The University of Queensland","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100635000","biofilm-induced-antimicrobial-resistance-risk-eradication-in-critical-care-central-venous-catheters-100635000","NCT07546994","Biofilm-induced Antimicrobial Resistance RIsk ERadication in Critical Care Central Venous Catheters","BARRIER","Inclusion Criteria:\n\n* Central venous catheters (conventional central venous lines, dialysis catheters, PICC lines) showing positive microbiological culture taken from adult patients in the critical care units (intensive care units, post-operative intensive care units and post-resuscitation intensive care units)\n* Patient consent is free, informed, and non-opposition, provided after delivery of an information letter and oral explanation.\n\nExclusion Criteria:\n\n* None",{"count":95,"type":20},150,"OBSERVATIONAL","Central venous catheter (CVC) infections are a frequent and serious nosocomial complication in critical care, leading to increased morbidity, mortality, and costs. The pathophysiology of these infections relies on the formation of a biofilm, an organized microbial structure that confers exceptional tolerance to anti-infectives and the immune system. However, data concerning the characteristics of the in vivo biofilm (kinetics, composition, endo- vs. extraluminal organization) on central venous catheters in intensive care patients are very limited, hindering the development of effective and targeted prevention strategies.\n\nThe main aim of this study is to quantify the density and describe the spatial distribution (extra- and intraluminal compartments) of the biofilm on infected or colonized central venous catheters, prospectively collected from patients in the critical care units.",[26,99,100],"Biofilms","Infection Prevention","2026-04-16",{"date":103,"type":31},"2026-04-23",{"date":105,"type":20},"2026-04",{"date":107,"type":20},"2028-04",{"name":109,"class":85},"Centre Hospitalier Universitaire de Nīmes",2,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":110},"100612844","analysis-of-microbial-biofilms-in-peripheral-venous-catheters-and-their-implication-in-infectious-risk-100612844","NCT07258862","Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk","KTBIO","Inclusion Criteria:\n\n* Patient hospitalized in a care unit of the NOVO hospital (Pontoise site)\n* Major patient for whom a peripheral venous catheter has been in place for at least 2 days and at most 7 days, with or without signs of inflammation\n\nExclusion Criteria:\n\n* Antibiotic treatment by any route\n* Patient with viral hepatitis, or human immunodeficiency virus (HIV) or suspected epidemic and biological risk (EBR)\n* Patient unable to understand and give non-opposition to study participation\n* Patient under guardianship",{"count":119,"type":20},250,"Peripheral venous catheters (PVCs) are the most commonly used intravascular medical devices in healthcare establishments. Although essential in patient care, PVCs represent a significant risk factor for nosocomial infections, as shown by the results of the national prevalence survey. While the main pathophysiological mechanisms are known, the specific factors driving the transition from simple colonization to infection remain unclear. This project aims to identify the major factors involved in the occurrence of bacterial infections related to the colonization of peripheral venous catheters.",[26],[123,124,26,99,125,126,127],"Vascular Access Devices","Peripheral Venous Catheter","Molecular Biology","Next-Generation Sequencing","Scanning Electron Microscopy","2025-11-21",{"date":130,"type":31},"2025-12-02",{"date":132,"type":20},"2026-01-01",{"date":134,"type":20},"2027-03-28",{"name":136,"class":85},"Hôpital NOVO",{"id":138,"slug":4,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":48,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":86},"100606404","NCT07175116","Advanced Dressings for CVC Infection Prevention in PICU","Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit","Inclusion Criteria:\n\n* Admission to paediatric intensive care unit (PICU)\n* Central venous catheter placement (central or peripherally inserted)\n* Informed consent obtained from parent\u002Flegal guardian\n\nExclusion Criteria:\n\n* Known immunological disorders\n* Neutropenia (\\\u003C500\u002Fmm³)\n* Pre-existing colonisation or infection with multidrug-resistant organisms","2 Months",{"count":119,"type":20},[52],"Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections (CVC-BSI) in paediatric patients admitted to a tertiary hospital PICU. Outcomes include incidence of BRCVC, catheter colonisation, dressing-related skin complications, and number of dressing changes.",[26,148,149,150],"Central Venous Catheters","Bloodstream Infection","Pediatric Intensive Care Units","2025-09-11",{"date":153,"type":31},"2025-09-16",{"date":155,"type":31},"2024-05-01",{"date":157,"type":20},"2025-11-15",{"name":159,"class":85},"University of Seville",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":192,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":86},"100585650","digital-transformation-of-continuity-of-care-for-peripherally-inserted-central-catheters-spadcare-experience-100585650","NCT06905119","Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience","SpadCare","Inclusion Criteria:\n\n* Patients \\>18 years.\n* Sign the informed consent form.\n* Have a Smartphone and accept the use of the APP.\n* Patient with a PICC inserted by the Infusion and Vascular Access Team of the University Hospital of Navarra and with a planned use of at least one month.\n\nExclusion Criteria:\n\n* Patients with limitations in the use of digital resources or lack of Smartphone.\n* Patients who do not want to install the APP on their Smartphone\n* Patients who do not authorize access to their Computerized Medical Record (HCI).",{"count":168,"type":20},201,[52],"The study focuses on patients who require outpatient infusion of therapy (\"Infusions, Intravenous\"\\[Mesh\\]) \"Administration, Intravenous\"\\[Mesh\\] (\"Home Infusion Therapy\"\\[Mesh\\]) \"Parenteral Nutrition, Home\"\\[Mesh\\] via a peripherally inserted central catheter (PICC) (\"Central Venous Catheters\"\\[MeSH\\] \"Catheterization, Central Venous\"\\[MeSH\\] \"Catheterization, Peripheral\" \\[MeSH\\] \"Vascular Access Devices\"\\[Mesh\\] )",[172,173,174,175,148,176,177,123,178,179,180,181,182,183,184,185,186,187,188,189,190,26,191],"Infusions, Intravenous","Administration, Intravenous","Home Infusion Therapy","Parenteral Nutrition, Home","Catheterization, Central Venous","Catheterization, Peripheral","Patient Education as Topic","Patient Participation","User-Computer Interface","Smartphone","Mobile Applications","Computers, Handheld","Digital Health","Nursing","Care Givers","Delivery of Health Care","Home Nursing","Self Administration","Adverse Effects","Telemedicine",[177,123,178,191,182],{"date":194,"type":31},"2025-09-12",{"date":196,"type":31},"2023-05-04",{"date":198,"type":20},"2026-07-31",{"name":200,"class":85},"Fundacion Miguel Servet",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":86},"100562492","phase-4-secondary-prevention-of-vte-in-patients-with-cancer-and-catheter-related-upper-extremity-deep-vein-thrombosis-100562492","NCT06603870","Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis","Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)","STREAM-Line","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.\n2. Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.\n3. Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Active bleeding or other reasons for which anticoagulation is contraindicated.\n2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).\n3. Anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days .\n4. Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy.\n5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.",{"count":210,"type":20},330,[23],"This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).",[214,215,216,26],"Venous Thromboembolism","Cancer","Upper Extremity Deep Vein Thrombosis","2025-05-26",{"date":219,"type":31},"2025-05-30",{"date":221,"type":31},"2024-12-19",{"date":223,"type":20},"2029-10",{"name":225,"class":85},"Ottawa Hospital Research Institute",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":234,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":242,"locationsCount":244},"100401943","expanded-access-mino-lok-therapy-mlt-for-the-treatment-of-crbsiclabsi-100401943","NCT04513821","Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI\u002FCLABSI","CITI-100 EA - Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Central Line Associated Bloodstream Infection","MLK","Inclusion Criteria:\n\n1. Subject or a legally authorized representative must provide a signed informed consent form;\n2. The subject should be male or female at least 12 years of age. This product has not been studied in a younger pediatric population;\n3. Subject should have a bloodstream infection with no other apparent source other than the CVC that meets one of the following criteria:\n\n   * A recognized single pathogen cultured from 1 or more blood cultures; OR\n   * A common skin contaminant cultured from 2 or more blood cultures drawn on the same or consecutive calendar days from a subject with fever (\\>38.0 C), chills, or hypotension (systolic blood pressure \\\u003C90 mmHg); Note that these criteria are based on the CDCs definition of CLABSI. Please consult the CDC website for guidance at https:\u002F\u002Fwww.cdc.gov\u002Fnhsn\u002Fpdfs\u002Fpscmanual\u002F4psc\\_clabscurrent.pdf.\n4. Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or required;\n5. This product has not been studied in women who are pregnant or lactating. It's effect on sperm development has also not been studied. Please consider this with female patients that are pregnant or who plan to become pregnant, or female patients who are breastfeeding. Likewise, male patients should refrain from sperm donation for 90 days following exposure to MLT. NOTE: Highly effective methods of contraception include hormonal contraceptives, intrauterine device, double-barrier method, partner sterility, or abstinence are strongly recommended.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria should not be exposed to MLT:\n\n1. Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;\n2. Subjects taking disulfiram at the time of enrollment or who are expected to take disulfiram at any time during treatment with study drug;\n3. The benefit of MLT in subjects with prosthetic cardiac valves, vascular grafts, pacers, automatic implantable cardioverter-defibrillator, or other non-removable vascular foreign body should be evaluated prior to exposure. The Investigator should be confident that these are not the source of infection;\n4. The benefit of MLT in subjects with a deep-seated intravascular source of infection (eg, endocarditis \\[as evidenced by vegetations on an echocardiogram or clinical suspicion\\] or septic thrombosis) should be evaluated prior to exposure. The Investigator should be confident that these are not the source of infection.","12 Years","EXPANDED_ACCESS","This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Central Line Associated Bloodstream Infection. Mino-Lok may be made available for patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717 )",[26],"AVAILABLE","2020-08-13",{"date":241,"type":31},"2020-08-14",{"name":243,"class":38},"Leonard-Meron Biosciences, Inc.",30]