[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gram-negative-bacteremia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gram-negative-bacteremia":125},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,73,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100522290","gram-negative-bloodstream-infection-oral-antibiotic-therapy-trial-100522290",false,"NCT06080698","Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial","GOAT","Inclusion Criteria:\n\n* Adult (≥ 18 years) at the time of screening\n* Hospitalized\n* Identification of at least one Gram-negative organism in a blood culture\n* Capable of providing written informed consent (includes through a legally authorized representative)\n* Willingness to adhere to assigned study arm\n* Capable and willing to complete a follow-up QoL interview (including through a legally authorized representative)\n\nExclusion Criteria:\n\n* Unable to tolerate or absorb a course of oral antibiotics\n* Actively receiving vasopressors\n* Gram-negative organism not susceptible to any oral antibiotics\n* Gram-negative organism not susceptible to any IV antibiotics\n* Polymicrobial bloodstream infection\n\n  * The following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative organism (except for Acinetobacter baumannii or Stenotrophomonas maltophilia), (2) a single positive blood culture with a common commensal organism (grown in addition to an Enterobacterales species or Pseudomonas aeruginosa\n* Allergy or contraindication rendering no oral option or no IV option for therapy with the listed antibiotic agents.\n* Anticipated duration of therapy greater than 14 days\n* Central nervous system infection\n* Absolute neutrophil count of \\\u003C500 cells\u002FmL or anticipated to reduce to \\\u003C500 cells\u002FmL during the antibiotic treatment course.\n* Receiving hospice care","ALL","18 Years",{"count":19,"type":20},1030,"ESTIMATED","INTERVENTIONAL",[23],"NA","The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on intravenous (IV) antibiotic therapy for the duration of treatment.",[26],"Gram-negative Bacteremia",[28,29,30,31,32,33,34],"Gram-negative bacteremia","Antibiotic treatment","Antibiotic route","Escherichia coli","Pseudomonas aeruginosa","Klebsiella pneumoniae","Desirability of outcome ranking (DOOR)","RECRUITING","2026-03-09",{"date":38,"type":39},"2026-03-11","ACTUAL",{"date":41,"type":39},"2024-02-22",{"date":43,"type":20},"2027-06-30",{"name":45,"class":46},"Johns Hopkins University","OTHER",11,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100557399","a-platform-trial-for-gram-negative-bloodstream-infections-100557399","NCT06537609","A Platform Trial for Gram Negative Bloodstream Infections","BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections","BALANCE+","PLATFORM INCLUSION CRITERIA\n\nPlatform Inclusion Criteria:\n\n* admitted to a participating hospital\n* positive blood culture with Gram negative (GN) bacterium\n\nPlatform Exclusion Criteria:\n\n* patient's goals of care are for palliation with no active treatment\n* moribund patient, not expected to survive \\> 72 hours\n* previously enrolled in the platform trial\n* not eligible for any domain at the time of screening\n\nDOMAIN SPECIFIC INCLUSION AND EXCLUSION CRITERIA\n\n1. De-escalation versus no de-escalation domain\n\n   Inclusion Criteria\n\n   \\- included in BALANCE+ platform\n\n   Exclusion Criteria\n   * receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive\n   * arbapenem-non-susceptible\n   * no de-escalation option due to any or all of:\n\n     * antimicrobial resistance\n     * allergies\n     * medical contraindications\n     * drug-drug interaction risk\n     * other relevant reason\n   * patients with a suspected or proven polymicrobial source of infection\n   * \\> 24 hours since index blood culture susceptibility results finalization\n2. Beta-lactam versus non-beta-lactam oral\u002Fenteral treatment domain\n\n   Inclusion Criteria\n   * included in BALANCE+ platform\n   * initially treated with intravenous antibiotics, but clinical team transitioning patient to oral\u002Fenteral antibiotic within 7 days of starting treatment\n\n   Exclusion Criteria\n   * enrolled in an arm of another BALANCE+ platform domain which limits the use of oral\u002Fenteral therapy:\n   * no-de-escalation arm (patients in the no de-escalation arm cannot be randomized into this domain unless they are ready for discharge home, in which case de-escalation is allowable to oral agents at discharge)\n   * no non-beta-lactam options due to any or all of:\n\n     * resistance\n     * allergies\n     * medical contraindications\n     * drug-interaction risk\n     * other relevant reason\n   * no beta-lactam options due to any or all of:\n\n     * resistance\n     * allergies\n     * medical contraindications\n     * drug-interaction risk\n     * other relevant reason\n   * pregnancy\n   * already received \\>24 hours of oral antibiotics after index blood culture finalization\n3. Central vascular catheter replacement domain\n\n   Inclusion Criteria\n   * included in BALANCE+ platform\n   * has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)\n\n   Exclusion Criteria\n   * patient has no ongoing need for a central vascular catheter\n   * patient has definite indication for central vascular catheter removal\n   * ongoing septic shock with definite\u002Fprobable line source\n\n     * concomitant S. aureus bacteremia\n     * concomitant candidemia\n   * local suppurative signs (severe redness, warmth, pain, swelling or fluctuance\u002Fcollection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging\u002Fechocardiographic findings)\n4. Low-risk AmpC domain\n\n   Inclusion Criteria\n   * included in BALANCE+ platform\n   * positive blood culture with GN bacterium, of the following species: i. Serratia spp. ii Morganella spp. iii Providencia spp. iv Proteus spp. other than P.mirabilis\n   * organism is susceptible to ceftriaxone\n\n   Exclusion Criteria\n   * severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS)\n   * baseline phenotypic non-susceptiblity to ceftriaxone\n   * more than 1 calendar day beyond availability of susceptibility results\n5. Follow up blood culture domain\n\nInclusion Criteria\n\n\\- included in BALANCE+ platform\n\nExclusion Criteria\n\n* patient died or discharged from hospital prior to day 4\n* blood culture already collected by the treating team at day 4±1\n* \\>5 days since index positive blood culture collection\n* definite indication for repeat blood culture testing\n\n  * concomitant S. aureus bacteremia\n  * concomitant Candidemia\n  * clinical suspicion for infective endocarditis","0 Years","130 Years",{"count":59,"type":20},2500,[23],"BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance.\n\nThe initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.",[26],"2026-02-06",{"date":65,"type":39},"2026-02-10",{"date":67,"type":39},"2024-04-24",{"date":69,"type":20},"2028-04",{"name":71,"class":46},"Sunnybrook Health Sciences Centre",39,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100608501","impact-of-real-time-mic-minimum-inhibitory-concentration-reporting-6-hours-on--lactam-prescription-in-cases-of-gram-negative-bacilli-bacteremia-in-icu-patients-in-real-life-settings-100608501","NCT07202377","Impact of Real-time MIC (Minimum Inhibitory Concentration) Reporting (\u003C6 Hours) on β-lactam Prescription in Cases of Gram-negative Bacilli Bacteremia in ICU Patients in Real-life Settings","CMIBActRéa","Inclusion Criteria:\n\n* Adult patients aged over 18 years\n* Patients with a positive blood culture for Gram-negative bacilli (Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii) with results reported on weekdays before 11:00 ante meridiem (AM)\n* Patients clinically suspected of infection\n* Treated with empirical antibiotic therapy including a β-lactam, among the standard list of antibiotics to be tested recommended by CASFM-EUCAST (European Committee on Antimicrobial Susceptibility Testing) for Enterobacterales\u002FPseudomonas and included in the Reveal Rapid AST System panel\n* Hospitalized in intensive care unit (ICU) for at least the next 24 hours\n* Written informed consent obtained from the patient or a relative for study participation (emergency consent)\n* Affiliated with the French social security system\n\nExclusion Criteria:\n\n* Patients receiving withdrawal or limitation of care\n* Patients with an expected survival prognosis of less than 72 hours\n* Patients with bloodstream infections caused by Gram-negative bacilli other than Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa\n* Patients treated with antibiotic therapy not including a β-lactam\n* Polymicrobial bloodstream infections\n* Pregnant or breastfeeding women\n* Patients under legal protection (guardianship or conservatorship)\n* Participation in another interventional research study",{"count":81,"type":20},200,[23],"Evaluate the impact of rapid, real-time (4 to 6 h) MIC reporting compared with the standard method (=diffusion antibiotic susceptibility testing) (18 to 24 h) on β-lactam prescribing in terms of the choice of molecule by the resuscitating clinician in the event of real-life Gram-negative Bacilli GNB bacteremia in the ICU.",[26,85],"Intensive Care Patients","NOT_YET_RECRUITING","2025-09-29",{"date":89,"type":39},"2025-10-01",{"date":91,"type":20},"2025-10",{"date":93,"type":20},"2026-11",{"name":95,"class":46},"Assistance Publique - Hôpitaux de Paris",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100384904","phase-4-shortened-antibiotic-treatment-of-5-days-in-gram-negative-bacteremia-100384904","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",{"count":105,"type":20},380,[107],"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%.",[26,110],"Urinary Tract Infection Bacterial",[28,112,113,114],"Urinary tract infection","Shortened antibiotic treatment","Bacterial infection","2023-02-06",{"date":117,"type":39},"2023-02-08",{"date":119,"type":39},"2020-03-11",{"date":121,"type":20},"2026-10-01",{"name":123,"class":46},"Thomas Benfield",13,"Gram Negative Bacteremia"]