[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gram-negative-bacterial-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gram-negative-bacterial-infections":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100488402","phase-2-study-of-2-medicines-aztreonam-and-avibactam-compared-to-best-available-therapy-for-serious-gram-negative-infections-100488402",false,"NCT05639647","Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections","A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION","Inclusion Criteria\n\nParticipants must meet the following key inclusion criteria to be eligible for enrollment into the study:\n\n1. Participants ≥9 months to \\\u003C18 years of age at Screening; Female (post-menarchal) participants must have a negative serum\u002Furine pregnancy test (β hCG sensitivity ≥25 mIU\u002FmL).\n2. Suspected\u002Fconfirmed cIAI, cUTI, HAP\u002FVAP, or BSI with gram-negative pathogens.\n3. Require hospitalization and IV antibiotic treatment.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded:\n\n1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n2. Gram-negative species not expected to respond to ATM AVI ≤14 days.\n3. Pregnant or breastfeeding; fertile male\u002Ffemale unwilling\u002Funable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.\n\n   (HAP\u002FVAP only):\n4. Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant.\n5. Received \\>24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.\n6. Current use of any prohibited concomitant medication(s) or unwilling\u002Funable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer).\n7. CrCL ≤15 mL\u002Fmin\u002F1.73 m2 (eCrCl or eGFR calculation based on age).\n8. Non-infectious related screening ALT or AST \\>3 x ULN, ALP \\>3 x ULN and\u002For TBili \\>2 x ULN (\\> 3 x ULN for Gilbert's syndrome).\n9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","ALL","9 Months","17 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.\n\nThe study is seeking participants who are:\n\n* 9 months to less than 18 years of age\n* Hospitalized\n* Suspected\u002Fknown to have a gram-negative infection\n* Receiving intravenous (iv, given directly into a vein) antibiotics\n* Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs.\n* Participants will receive either ATM-AVI or best available therapy (BAT).\n* Both therapies will be given through a vein.\n* Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of MTZ. - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion.\n* The iv dose of ATM-AVI will be based on the participant's weight and kidney function.\n* The study doctor will determine the iv dose of BAT.\n* During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities.\n* Starting on day 4, the study doctor will decide if participants may be switched to oral therapy.\n* Participants will receive a maximum of 14 days of ATM-AVI treatment.\n* After discharge from the hospital, 1 study visit may be required.\n* Depending on the participant's response, the study duration will be from 33 to 50 days.\n* The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.",[27],"Gram-negative Bacterial Infections",[29],"Gram-negative bacterial infections","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2023-04-18",{"date":38,"type":21},"2027-03-31",{"name":40,"class":41},"Pfizer","INDUSTRY",23,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"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).","18 Years",{"count":52,"type":21},234,[24],"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.",[56,57,58],"Gram Negative Pneumonia","Gram-Negative Bacterial Infections","Bacteremia Caused by Gram-Negative Bacteria","2025-06-18",{"date":61,"type":34},"2025-06-24",{"date":63,"type":34},"2023-11-06",{"date":65,"type":21},"2025-12-31",{"name":67,"class":68},"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation","OTHER"]