[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Thomas Benfield\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100384904","phase-4-shortened-antibiotic-treatment-of-5-days-in-gram-negative-bacteremia-100384904",false,"NCT04291768","Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia","Short Course Antibiotic Treatment of Gram-negative Bacteremia: A Multicenter, Randomized, Non-blinded, Non-inferiority Interventional Study","GNB5","Inclusion Criteria:\n\n* Age \\>18 years\n* Blood culture positive for Gram-negative bacteria\n* Evidence of urinary tract source of infection (positive urine culture or at least one clinical symptom compatible with urinary tract infection)\n* Antibiotic treatment with antimicrobial activity to Gram-negative bacteria administrated within 12 hours of first blood culture\n* Temperature \\\u003C37.8°C at randomization\n* Clinically stabile at randomization (systolic blood pressure \\> 90 mm Hg, heart rate \\\u003C100 beats\u002Fmin., respiratory rate \\\u003C24\u002Fminute, peripheral oxygen saturation \\> 90 %)\n* Oral and written informed consent\n\nExclusion Criteria:\n\n* Antibiotic treatment (\\>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days of inclusion\n* Gram-negative bacteremia within 30 days of blood culture\n* Immunosuppression (Untreated HIV-infection, Neutropenia (absolute neutrophil count \\\u003C 1.0 x 109\u002Fl), Untreated terminal cancer, Receiving immunosuppressive agents (ATC-code L04A), Corticosteroid treatment (≥20 mg\u002Fday prednisone or the equivalent for \\>14 days) within the last 30 days, Chemotherapy within the last 30 days, Immunosuppressed after solid organ transplantation, Asplenia)\n* Polymicrobial growth in blood culture\n* Bacteremia with non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp\n* Failure to remove source of infection within 72 hours of first blood culture (e.g. change of catheter á demeure)\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":20,"type":21},380,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","GNB5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic for patients hospitalized with a Gram negative bacteremia with a urinary tract source of infection (GNB).\n\nFive days after initiation of antimicrobial therapy for GNB, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.\n\nThe primary outcome is 90-day survival without clinical or microbiological failure to treatment, which will be tested with a non inferiority margin of 10%.",[27,28],"Gram-negative Bacteremia","Urinary Tract Infection Bacterial",[30,31,32,33],"Gram-negative bacteremia","Urinary tract infection","Shortened antibiotic treatment","Bacterial infection","RECRUITING","2023-02-06",{"date":37,"type":38},"2023-02-08","ACTUAL",{"date":40,"type":38},"2020-03-11",{"date":42,"type":21},"2026-10-01",{"name":44,"class":45},"Thomas Benfield","OTHER",13,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100429726","phase-4-safety-and-immunogenicity-following-meningococcal-and-pneumococcal-immunization-among-adult-people-living-with-hiv-100429726","NCT04875819","Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV","Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial","MENPI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Seropositive for HIV-1\n* Recipient of ART\n* Plasma HIV-RNA \\\u003C 500 copies\u002Fml\n* Patients written consent obtained\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* History of meningococcal or pneumococcal vaccination\n* Allergies towards any of the vaccine components\n* Temperature \\> 38 ᵒC\n* Sign of bacterial infection\n* Previous known or suspected disease caused by N. meningitidis\n* Active AIDS associated illness\n* Active malignancy\n* End-stage renal or liver disease\n* Bleeding disorder\n* Recipient of any blood, blood products and\u002For plasma derivatives or any parenteral immunoglobulin preparation within the last month\n* Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)",{"count":56,"type":21},55,[24],"MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.\n\nParticipants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®\u002FPneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.\n\nImmunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.",[60,61,62],"Hiv","Meningococcal Infections","Pneumococcal Infections","2021-05-05",{"date":65,"type":38},"2021-05-06",{"date":67,"type":38},"2021-04-28",{"date":69,"type":21},"2026-12",{"name":44,"class":45},1,""]