[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacteremia-caused-by-gram-negative-bacteria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacteremia-caused-by-gram-negative-bacteria":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100590351","a-post-marketing-study-to-assess-the-efficacy-and-safety-of-intravenous-polymyxin-b-and-colistin-methanesulfonate-in-patients-with-carbapenem-resistant-gram-negative-bacterial-infection-100590351",false,"NCT06966284","A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection","A Retrospective, Observational, Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Infusions Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection","Inclusion Criteria:\n\n1. Patient ≥ 18 years of age.\n2. Patient diagnosed with bacterial pneumonia and\u002For bacteremia, or other physician judged serious infection (except urinary tract infection, UTI) caused by Carbapenem-Resistant Gram-Negative Bacteria (CR-GNB).\n\n   CR-GNB: Resistant to at least one of the carbapenem antibiotics or produce a carbapenemase (an enzyme that can make them resistant to carbapenem antibiotics).\n\n   Diagnosis Criteria of HABP\u002FVABP:\n\n   • Met the clinical diagnosis criteria for HABP\u002FVABP. HABP: Acute bacterial pneumonia in a subject hospitalized for more than 48 hours or developing within 7 days after discharge from a hospital. Subject could have experienced acute respiratory failure and required mechanical ventilation for HABP.\n\n   VABP: Acute bacterial pneumonia in a subject receiving mechanical ventilation via an endotracheal (or nasotracheal) tube for a minimum of 48 hours.\n   * ≥ 1 of the following clinical features: new onset or worsening of pulmonary symptoms or signs, hypoxemia, need for acute changes in the ventilator support system to enhance oxygenation, new onset of or increase in suctioned respiratory secretions.\n   * ≥ 1 of the following signs: documented fever, hypothermia, WBC ≥ 10,000 cells\u002Fmm3, WBC ≤ 4500 cells\u002Fmm3, \\>15% immature neutrophils(bands)\n   * CXR or lung CT: presence of new or progressive infiltrates suggestive of bacterial pneumonia.\n\n   Diagnosis Criteria of BSI\u002FBacteremia: the BSI\u002Fsepsis category included bacteremia or sepsis caused by infections other than HABP\u002FVABP, or UTI:\n   * Documented BSI caused by a carbapenem-resistant Gram-negative pathogen; or\n   * Systemic response to infection, meeting the clinical criteria of SIRS and an identified infection source (eg, severe skin infection, intra-abdominal infection) caused by a carbapenem-resistant Gram-negative pathogen.\n3. Patient received intravenous polymyxin B or CMS treatment for ≥72 h.\n4. Administration of polymyxin B or CMS within 7 days from the infection onset day.\n\nInfection onset day: The date of specimen collection for index pathogen.\n\nExclusion Criteria:\n\n1. Patient with bacteremia caused by urinary tract infection.\n2. CR-GNB known to be resistant to polymyxin B or CMS.\n3. Patient has infectious disease (s) caused by the following gram-negative bacteria which are known to have no response to polymyxin B and\u002For colistin treatment: Proteus spp., Providencia spp., Morganella spp., Serratia marcescens, Burkholderia spp., and Neisseria spp.\n4. Intravenous administration of polymyxin B or colistin more than 28 days.\n5. Both the treatment efficacy and safety could not be evaluated.","ALL","18 Years",{"count":19,"type":20},480,"ESTIMATED","OBSERVATIONAL","This is a retrospective, observational, post-marketing study to evaluate the clinical response, microbiological response, mortality, and safety of intravenous polymyxin B and colistin methanesulfonate in patients with carbapenem-resistant gram-negative bacterial infection. Subgroup analysis by sites of infection, infectious pathogens, and baseline renal function will also be performed.",[24,25],"Bacteremia Caused by Gram-Negative Bacteria","Bacterial Pneumonia",[27],"polymyxin B sulfate","RECRUITING","2026-03-05",{"date":31,"type":32},"2026-03-09","ACTUAL",{"date":34,"type":32},"2025-11-26",{"date":36,"type":20},"2028-11-30",{"name":38,"class":39},"TTY Biopharm","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100526485","phase-2-clinical-trial-to-study-the-efficacy-and-safety-of-fluorothiazinone-nf-gamaleya-nrcem-in-prophylaxis-of-nosocomial-bacterial-infections-with-participation-of-patients-on-mv-100526485","NCT06135350","Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV","A Randomized, Double-blind, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of the Drug Fluorothiazinone (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on Mechanical Ventilation","Inclusion Criteria:\n\n1. Patient's written consent to participate in the study in accordance with the current legislation or the decision of the board in case of absence of consciousness of the patient.\n2. Patients are at least 18 years old, male and female.\n3. Patients who are in the ICU (intensive care unit).\n4. Patients with:\n\n   4.1. Laboratory confirmed SARS-CoV-2 (Severe acute respiratory syndrome-related coronavirus-2) on screening (a patient's coronavirus infection can be confirmed either before admission to the hospital (for outpatient treatment) or when admitted to the hospital) by RT-PCR (reverse transcription polymerase chain reaction) AND severe community-acquired pneumonia in ICU with evidence of viral lung injury and symptoms of respiratory failure:\n   * SpO2 (peripheral oxygen saturation) ≤ 93%;\n   * Lung changes of 3rd- to 4th-degree according to CT (results of computed tomography), consistent with viral involvement; OR 4.2. Acute stroke; OR 4.3. Acute heart failure: Cardiogenic shock of any cause, pulmonary edema, or acute decompensated chronic heart failure.\n5. Patients who have been on ALV (artificial lung ventilation) for no more than 12 hours.\n6. Patients who are according to the investigator are at high risk to be transferred to ALV within 72 hours of the initiation of the therapy.\n7. All women of childbearing age and men with partners of childbearing age should agree to use an effective contraceptive methods (e.g., implants, infections, combination oral contraceptives, intrauterine device, abstinence, vasectomy or vasectomy partner) during the entire study.\n\nExclusion Criteria:\n\n1. The patient was not switched to ALV within 72 hours (3 days) after receiving the investigational drug.\n2. People who have a bloodstream infection, identified during the screening.\n3. A patient may terminate his\u002Fher participation in the study at any time for any reason and without any explanation.\n\n3\\. The investigator may also decide to terminate the patient's participation at any time if it is required due to the patient's condition.\n\n4\\. The sponsor or the regulator may also request the trial to be terminated early, either due to how the trial was conducted, or due to application safety data, or other reasons.\n\n5\\. The main reasons why the patient may withdraw from the study are:\n\n* Refusal of the patient to participate in the study;\n* Development of an AE (adverse event) \u002F SAE (serious adverse event) that prevents further study participation;\n* The occurrence of concomitant somatic diseases \u002F symptoms or exacerbation of chronic diseases not related to the investigational drug (at the discretion of the medical investigator).",{"count":49,"type":20},234,"INTERVENTIONAL",[52],"PHASE2","This study is designed to evaluate the clinical and antibacterial efficacy, safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation of patients on mechanical ventilation.\n\nThe main objectives of this study are:\n\n* Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation.\n* Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation.\n* Evaluation of the pharmacokinetics (in whole blood) of the drug Fluorothiazinone with a single daily dose of 2400 mg\u002Fday.\n\nResearchers will compare results for the treatment and the placebo arms.",[55,56,24],"Gram Negative Pneumonia","Gram-Negative Bacterial Infections","2025-06-18",{"date":59,"type":32},"2025-06-24",{"date":61,"type":32},"2023-11-06",{"date":63,"type":20},"2025-12-31",{"name":65,"class":66},"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation","OTHER"]