[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clinical Research Centre, Malaysia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100541973","phase-3-early-intravenous-to-oral-antibiotic-switch-in-uncomplicated-staphylococcus-aureus-bacteraemia-100541973",false,"NCT06336824","Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia","Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia: The EVOS Randomized Controlled Trial","EVOS","Inclusion Criteria:\n\n1. Blood culture positive for Staphylococcus aureus (S. aureus).\n2. Received 3 to 7 days of definitive IV antimicrobial therapy, defined as:\n\n   * Cloxacillin or cefazolin for methicillin-sensitive staphylococcus aureus (MSSA); Vancomycin or ceftaroline for methicillin-resistant staphylococcus aureus (MRSA).\n   * Proven in-vitro susceptibility and adequate dosing given (as determined by the principal investigator).\n3. Achieved clearance of bacteraemia, defined as at least one documented latest negative follow-up blood culture obtained within 72 hours after the initiation of definitive IV antimicrobial therapy.\n4. Achieved defervescence, defined as sustained body temperature ≤37.5°C within 48 hours before randomization.\n5. Able to provide written informed consent to participate trial.\n\nExclusion Criteria:\n\n1. Evidence of metastatic infection of S. aureus: for example, infective endocarditis, intraabdominal abscess, lung empyema, and osteomyelitis. Radiological investigations such as chest X-ray, ultrasound, echocardiogram, and CT scan are not mandatory prior to enrolment, but should be done at the discretion of the treating physician if clinically indicated.\n2. Septic shock, defined as hypotension requiring vasopressors to maintain MAP ≥65 mmHg despite adequate volume resuscitation.\n3. Received more than 5 days of non-study antibiotics as empirical therapy prior to enrolment.\n4. Polymicrobial bloodstream infection, defined as isolation of pathogens other than S. aureus from a blood culture obtained prior to randomization. Common skin contaminants such as coagulase-negative staphylococci, Bacillus spp., and diphtheroid will not be considered to represent polymicrobial infection.\n5. Known history of S. aureus infection within the past 3 months.\n6. Inability to tolerate oral therapy or poor absorption of oral medications, or not suitable for ongoing IV therapy (for example, difficult intravenous access)\n7. No options of oral antibiotic available for patient due to:\n\n   * In vitro resistance of S. aureus to all oral study drugs.\n   * Known contraindications to receive the active oral study drugs. For example, hypersensitivity reaction to trimethoprim-sulfamethoxazole, thrombocytopenia secondary to linezolid etc.\n   * Non-availability of oral study drugs at the study sites.\n8. Patient is concomitantly receiving oral antibiotics which are active against S. aureus. For example, trimethoprim-sulfamethoxazole for Pneumocystis jirovecii pneumonia prophylaxis.\n9. Presence of a non-removable foreign body such as prosthetic heart valve, vascular graft, pacemaker, automated implantable cardioverter-defibrillator, ventriculoperitoneal shunt, prosthetic joint, and fracture fixation implant\n10. Failure or inability to remove intravascular catheter that is present when first positive blood culture was drawn.\n11. Known comorbidity that increased the risk of complicated infections:\n\n    * End-stage renal disease\n    * Severe liver disease (Child-Pugh class C)\n    * Severe immunodeficiency:\n\n      * HIV-positive patients with CD4\\\u003C200 cells\u002FuL or AIDS\n      * primary immunodeficiency disorders\n      * high-dose steroid therapy (\\>1 mg\u002Fkg prednisone or equivalent doses given for \\> 4 weeks or planned during intervention)\n      * immunosuppressive therapy\n      * neutropenia (\\\u003C500 neutrophils\u002Fμl) at randomization or neutropenia expected during intervention phase due to immunosuppressive treatment\n      * solid organ or hematopoietic stem cell transplantation within the past 6 months or planned during treatment period\n\n13.Short life expectancy \\\u003C 3 months\n\n14.Pregnancy (for women of childbearing potential)","ALL","18 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB.",[27],"Staphylococcus Aureus Bacteremia",[29,30,31],"bacteremia","oral antibiotics","Staphylococcus aureus","RECRUITING","2024-07-02",{"date":35,"type":36},"2024-07-05","ACTUAL",{"date":38,"type":36},"2024-06-28",{"date":40,"type":21},"2025-06",{"name":42,"class":43},"Clinical Research Centre, Malaysia","OTHER",12,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100503985","phase-2-effect-of-high-dose-intravenous-vitamin-c-in-severe-pneumonia-100503985","NCT05842382","Effect of High Dose Intravenous Vitamin C in Severe Pneumonia","Effect of High Dose Intravenous Vitamin C as an Adjunct in the Treatment of Patients With Severe Pneumonia in Intensive Care Unit: a Multi-center, Double-blinded, Two-arm, Placebo-controlled, Randomized Trial","VICSEP","Inclusion Criteria:\n\n* Patients who are aged 18 and above\n* Patients who are diagnosed with severe pneumonia\n* Patients who are mechanically ventilated\n\nExclusion Criteria:\n\n* Known allergy to Vitamin C\n* Pregnancy\n* Known history of ongoing concomitant infection\n* Participation in another clinical trial and\u002For receipt of investigational drugs within 4 weeks prior to enrollment\n* Moribund patient with multiorgan failure to the judgement of the treating physician, who is not expected to survive 24 hours\n* Patient who requires home oxygen therapy or mechanical ventilation, including tracheostomy or non-invasive ventilation, except for CPAP\u002FBIPAP for sleep-disordered breathing\n* Known history of previous or current diagnosis of renal stones\n* Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* Known diagnosis of hemochromatosis\n* Known diagnosis of poorly controlled chronic pulmonary disease, including:\n\n  * Chronic obstructive pulmonary disease with oxygen therapy\n  * Chronic restrictive pulmonary disease with oxygen therapy\n  * Bronchial asthma on Step 5 of treatment ladder as shown in Pocket Guide for Asthma Management and Prevention\n  * Lung cancer in Stage IV of disease\n* Known diagnosis of heart failure on anti-failure treatment or requiring mechanical hemodynamic support (e.g. LVAD), with recent hospitalization within 3 months (90 days) from the date of current admission.\n* Immunocompromised state\n* Known diagnosis of malignancy and ongoing chemotherapy or radiotherapy as there is evidence that antioxidant supplement before and during treatment was associated with an increased hazard of recurrence\n* Known diagnosis of malignancy who had completed chemotherapy or radiotherapy with absolute neutrophil count ≤100 cells\u002Fmm3\n* Known diagnosis of Stage 4 and above chronic kidney disease (GFR \\\u003C30 ml\u002Fmin\u002F1.73m2) and end-stage renal disease on regular dialysis (including peritoneal dialysis or hemodialysis)\n* Known history of renal transplantation\n* Absence of family members or next of kin for informed consent",{"count":54,"type":21},484,[56],"PHASE2","This trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU.",[59],"Pneumonia",[61,62,63,64,65,66],"Severe pneumonia","Critically ill","Ascorbic acid","Vitamin C","Mechanical ventilation","Ventilation-free day","2024-06-17",{"date":69,"type":36},"2024-06-20",{"date":71,"type":36},"2024-01-12",{"date":73,"type":21},"2026-02",{"name":42,"class":43},3,""]