[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gram-positive-bacterial-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gram-positive-bacterial-infections":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100635277","phase-2-oritavancin-for-treatment-of-serious-cardiac-infections-100635277",false,"NCT07550595","Oritavancin for Treatment of Serious Cardiac Infections","A Multicentre Phase II Prospective Pilot Study of Pharmacokinetic- and TDM-guided Oritavancin Dosing Strategies for the Management of Gram-positive Cardiac Infections (the OSCAR Study)","OSCAR","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Hospitalised for management of a cardiac infection (infective endocarditis or cardiovascular implantable electronic device infections)\n3. Gram-positive organism identified in blood or tissue culture, that in the opinion of the investigator is the cause of cardiac infection and would be treatable with a finite antibiotic duration (e.g., 4-6 weeks)\n4. Afebrile for at least 24 hours at screening\n5. Clearance of blood cultures for at least 24 hours at screening\n6. Receiving effective antibiotic therapy for at least 24 hours and no more than 14 days at screening\n7. Willingness of both treating provider and participant to proceed with oritavancin therapy\n8. Able to provide written informed consent\n9. Willingness and ability to participate in study procedures, including follow-up visits and drug monitoring\n\nExclusion Criteria:\n\n1. History of severe allergic reaction or hypersensitivity to oritavancin or any of its components\n2. Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or currently receiving dialysis\n3. Severe hepatic impairment (Child-Pugh class C)\n4. Current infection involving the central nervous system, including septic emboli, ischemic or haemorrhagic stroke, epidural abscess, or meningitis (excluding prior\u002Funrelated central nervous system events).\n5. Presence of prosthetic heart valve\n6. Culture negative endocarditis\n7. Presence of any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes\n8. Infection with Gram positive organism not susceptible to oritavancin or vancomycin (vancomycin MIC \\> 2 μg\u002FmL).\n9. Use of contraindicated medications (see Section 8)\n10. Participation in another interventional clinical trial that may confound study outcomes\n11. Pregnant or breastfeeding people, or those planning to become pregnant during the study period (people of childbearing potential must have a negative pregnancy test during hospitalization and use effective contraception for trial duration and for 3 months after last infusion of study medication).\n12. Immunosuppression (defined as active chemotherapy expected to cause absolute neutrophil count \\\u003C100 cells\u002Fmm3 lasting \\>7 days during the study period, bone marrow transplantation in the preceding 90 days, solid organ transplantation within prior 3 months or receipt of augmented immunosuppression for rejection within 3 months, chronic granulomatous disease, HIV with a CD4 count \\\u003C50 cells\u002Fmm3 based on last known measure).\n13. Any condition (e.g. severe cognitive impairment, psychiatric illness, active withdrawal) that, in the opinion of the investigator, would limit the participant's ability to comply with study procedures or give informed consent\n14. Medically unstable in opinion of treating clinician that would preclude participation\n15. Cases in which the investigator deem curative or finite antibiotic treatment unlikely (e.g., long term indefinite suppressive antibiotics are likely such as retained hardware).","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Cardiac infections, including infective endocarditis and cardiovascular implantable electronic device infections, are associated with substantial morbidity and mortality and are commonly caused by gram-positive bacteria. Standard management typically requires prolonged courses of intravenous antibiotics and extended hospitalisation, which are costly, burdensome, and associated with complications related to long-term vascular access. People who inject drugs are disproportionately affected and often experience stigma, barriers to care, and poorer outcomes. Long-acting lipoglycopeptides such as oritavancin maintain therapeutic serum concentrations for prolonged periods and may offer an alternative to conventional intravenous antibiotic regimens. Oritavancin is not TGA-registered in Australia and is accessed as an unregistered medicine (for example, via SAS or clinical trials). It is approved in other jurisdictions, including the United States and European Union, for acute bacterial skin and skin structure infections. Prospective data in cardiac infections remain limited, and optimal dosing strategies, including the role of therapeutic drug monitoring, are uncertain. This multicentre, open-label pilot study will assess the feasibility, pharmacokinetics, safety, acceptability, and preliminary efficacy of oritavancin for gram-positive cardiac infections using both standard fixed dosing and TDM-guided dosing strategies. Findings will inform PK\u002FPD modelling, the potential role of TDM, and the design of future larger-scale trials and models of care, including alternatives to prolonged inpatient intravenous therapy.",[27,28,29],"Infective Endocarditis","Cardiac Device Infection","Gram-positive Bacterial Infections",[31,32,33,34,35,36,37,38],"Oritavancin","Long-acting antibiotic","Lipoglycopeptide","Infective endocarditis","Cardiac device infection","Gram-positive infection","Therapeutic drug monitoring","Pharmacokinetics","NOT_YET_RECRUITING","2026-04-23",{"date":42,"type":43},"2026-04-29","ACTUAL",{"date":45,"type":21},"2026-07-01",{"date":47,"type":21},"2028-09-30",{"name":49,"class":50},"Kirby Institute","OTHER_GOV",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100550263","phase-3-model-informed-precision-dosing-for-linezolid-100550263","NCT06444802","Model-informed Precision Dosing for Linezolid","Model-informed Precision Dosing for Linezolid: a Pilot Randomized Clinical Trial","LINEMAP","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each\n3. with written informed consent of the patient or\n4. with written informed consent of his\u002Fher legal representative or\n5. after using the option of inclusion via spouse according to § 1358 BGB or\n6. after application of the independent consultant procedure\n7. Patients of childbearing age: negative pregnancy test\n\nExclusion Criteria:\n\n1. Patients receiving antibiotics active against Gram-positive bacteria at the same time of linezolid\n2. Infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis\n3. Death is deemed imminent and inevitable\n4. Pregnancy\n5. Lactation\u002Fbreastfeeding",{"count":60,"type":21},28,[62],"PHASE3","Study Rationale: Previous in vitro and retrospective in vivo studies suggest that optimal linezolid concentrations (between 2 and 7 mg\u002FL) achieve clinical efficacy and microbiological eradication while minimizing side effects like thrombocytopenia and the emergence of resistance. No prospective or randomized clinical trial has confirmed these findings, and there is no consensus on how to adjust linezolid dosing to achieve optimal drug concentrations.\n\nObjectives: The primary objective is to determine if model-informed precision dosing optimizes linezolid dosing to achieve therapeutic trough concentrations compared to a standard dose. Secondary objectives include assessing the PK\u002FPD profile, investigating the prevalence of linezolid resistance among gram-positive bacteria, assessing microbiological resolution of infection, and evaluating the safety and tolerability of linezolid.\n\nMethodology: This study is an open, monocentric pilot randomized controlled trial with two arms: standard dose therapy versus dose adjustment based on model-informed precision dosing using therapeutic drug monitoring and PK\u002FPD targets developed in TMDx software.\n\nSample Size: 28 patients, 14 in each group. Assumptions are based on only 25% of patients in intensive care achieving the optimal therapeutic range with standard dosing, compared to an expected 80% achieving this with model-informed precision dosing.\n\nSelection Criteria: Adult patients (18+ years) already starting linezolid treatment for gram-positive infections, expected to require treatment beyond the next calendar day. Exclusions include imminent death, expected or confirmed pregnancy, expected linezolid treatment of less than 4 days or more than 4 weeks.\n\nOutcomes: The primary endpoint is defined as the difference in the proportion of patients in the intervention and in the control groups who maintained a trough linezolid concentration of 2 to 7 mg\u002FL on Day 7 and Day 13.",[65],"Gram-Positive Bacterial Infections",[67,68,69],"Linezolid","PK-PD Model","TDM","2024-05-30",{"date":72,"type":43},"2024-06-06",{"date":74,"type":21},"2024-09-01",{"date":76,"type":21},"2026-06-30",{"name":78,"class":79},"University of Hamburg-Eppendorf","OTHER",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100502648","drug-exposure-and-minimum-inhibitory-concentration-in-the-treatment-of-mac-lung-disease-100502648","NCT05824988","Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease","Drug Exposure and Minimum Inhibitory Concentration in the Treatment of Mycobacterium Avium Complex Lung Disease: a Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Culture-positive MAC lung disease\n* MAC treatment at the Shanghai Pulmonary Hospital\n* A regimen composed of at least the core drugs, i.e., macrolides, rifamycin and ethambutol, in doses not lower than recommended according to the ATS\u002FERS\u002FESCMID\u002FIDSA and Chinese national guidelines\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Confirmed mixed infection with mycobacterial species, including M.tuberculosis and other NTM species\n* Ongoing with any antimycobacterial treatment for more than one month, including tuberculosis and NTM\n* Patients admitted to the intensive care unit\n* Off-label use for any study drugs, such as inhalation of amikacin",{"count":88,"type":21},100,"OBSERVATIONAL","The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3). In China, Mycobacterium avium complex (MAC) was the most prevalent NTM specie (4), while challenged by long treatment duration, frequent drug-induced adverse events, lack of treatment alternatives, poor treatment outcome and high recurrence rate (5, 6). In order to maximize the efficacy of the few available drugs and prevent the development of drug resistance, ensuring adequate plasma drug concentrations are of importance. Despite the role of pathogen susceptibility, determined by minimum inhibitory concentration (MIC), is non-negligible, the evidences regarding its association with treatment outcome are limited, especially for rifamycin and ethambutol. The difficulties in explaining the clinical values of MIC might partially be attributed to the lack of in vivo drug exposure data, which cannot be accurately predicted by the dose administered because of between-patient pharmacokinetic variability (7). Therapeutic drug monitoring (TDM) is a strategy to guide and personalize treatment by measuring plasma drug concentrations and pathogen susceptibility, which might have the potential to improve treatment response to MAC lung disease.\n\nIn this observational study, the hypothesis is that the drug exposure and\u002For MIC of antimycobacterial drugs are correlated to the treatment response of MAC lung disease, which is assessed from the perspective of treatment outcome, mycobacterial culture negative conversion, lung function, radiological presentation and self-reported quality of life. Consenting adult patients with culture-positive MAC lung disease will be recruited in study hospital. Respiratory samples (sputum and\u002For bronchoalveolar lavage fluid) will be collected regularly for mycobacterial culture on the basis of BACTEC MGIT 960 system and MIC will be determined using a commercial broth microdilution plate. Drug concentrations will be measured at 1 and\u002For 6 months after treatment initiation using liquid chromatography tandem mass spectrometry (LC-MS\u002FMS). The final treatment outcome is recorded at the end of MAC treatment and defined according to an NTM-NET consensus statement (8).",[92,93,65,94],"Mycobacterium Avium Complex","Mycobacterium Avium-Intracellulare Infection","Mycobacterium Infections",[96,97,98,38,99],"Treatment","Minimum Inhibitory Concentration","Drug Concentration","Pharmacodynamics","RECRUITING","2024-01-19",{"date":103,"type":43},"2024-01-22",{"date":105,"type":43},"2023-04-14",{"date":107,"type":21},"2026-10",{"name":109,"class":79},"Shanghai Pulmonary Hospital, Shanghai, China",1]