[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488402":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":266,"collaborators":41,"id":268,"slug":269,"hasResults":270,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":41,"eligibilityCriteria":274,"healthyVolunteers":270,"sex":275,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":41,"studyType":281,"phases":282,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ATM-AVI","EXPERIMENTAL","ATM-AVI administered iv every 6 or 8 hours and dosed according to participant's weight and kidney function for up to 14 days depending on response. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv ATM-AVI therapy",[13],"Drug: ATM-AVI",{"label":15,"type":16,"description":17,"interventionNames":18},"Best available therapy (BAT)","ACTIVE_COMPARATOR","BAT will be selected by the investigator and administered iv. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv BAT",[19],"Drug: BAT",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","A drug specifically designed to treat resistant gam-negative bacterial infections",[9],[26],"aztreonam plus avibactam",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BAT","BAT will be selected by the investigator and administered iv as appropriate for the selected drug(s)",[15],[32],"Best available therapy",[34],{"name":35,"affiliation":5,"role":36},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","1-800-718-1021",null,"ClinicalTrials.gov_Inquiries@pfizer.com",[44,58,67,73,85,95,104,116,126,137,142,154,164,174,186,195,205,214,220,231,240,249,256],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":41},"Rady Children's Hospital","RECRUITING","San Diego","California","92123","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.16472,32.71571,{"lat":56,"lon":55},{"facility":59,"status":46,"city":60,"state":60,"zip":61,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":66,"contacts":41},"Weill Cornell Medicine-New York Presbyterian Hospital","New York","10021",{"type":53,"coordinates":63},[64,65],-74.00597,40.71427,{"lat":65,"lon":64},{"facility":68,"status":46,"city":60,"state":60,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":72,"contacts":41},"Icahn School of Medicine at Mount Sinai","10029",{"type":53,"coordinates":71},[64,65],{"lat":65,"lon":64},{"facility":74,"status":46,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":41},"Beijing Children's Hospital, Capital Medical University","Beijing","Beijing Municipality","100045","China","CN",{"type":53,"coordinates":81},[82,83],116.39723,39.9075,{"lat":83,"lon":82},{"facility":86,"status":46,"city":87,"state":88,"zip":89,"country":78,"countryCode":79,"cosmosGeoPoint":90,"geoPoint":94,"contacts":41},"Guangzhou Women and Children's Medical Center","Guangzhou","Guangdong","510623",{"type":53,"coordinates":91},[92,93],113.25,23.11667,{"lat":93,"lon":92},{"facility":96,"status":46,"city":97,"state":41,"zip":98,"country":78,"countryCode":79,"cosmosGeoPoint":99,"geoPoint":103,"contacts":41},"Shanghai Children's Medical Center","Shanghai","200127",{"type":53,"coordinates":100},[101,102],121.45806,31.22222,{"lat":102,"lon":101},{"facility":105,"status":46,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":41},"University General Hospital of Heraklion","Heraklion","Irakleío","715 00","Greece","GR",{"type":53,"coordinates":112},[113,114],25.14341,35.32787,{"lat":114,"lon":113},{"facility":117,"status":46,"city":118,"state":119,"zip":120,"country":109,"countryCode":110,"cosmosGeoPoint":121,"geoPoint":125,"contacts":41},"Ippokrateio General Hospital of Thessaloniki","Thessaloniki","Kentrikí Makedonía","546 42",{"type":53,"coordinates":122},[123,124],22.93493,40.64072,{"lat":124,"lon":123},{"facility":127,"status":46,"city":128,"state":41,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":41},"Semmelweis Egyetem","Budapest","1083","Hungary","HU",{"type":53,"coordinates":133},[134,135],19.04045,47.49835,{"lat":135,"lon":134},{"facility":127,"status":46,"city":128,"state":41,"zip":138,"country":130,"countryCode":131,"cosmosGeoPoint":139,"geoPoint":141,"contacts":41},"1094",{"type":53,"coordinates":140},[134,135],{"lat":135,"lon":134},{"facility":143,"status":46,"city":144,"state":145,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":41},"RajaRajeswari Medical College and Hospital","Bangalore","Karnataka","560074","India","IN",{"type":53,"coordinates":150},[151,152],77.59369,12.97194,{"lat":152,"lon":151},{"facility":155,"status":46,"city":156,"state":157,"zip":158,"country":147,"countryCode":148,"cosmosGeoPoint":159,"geoPoint":163,"contacts":41},"Medanta Hospital Lucknow","Lucknow","Uttar Pradesh","226030",{"type":53,"coordinates":160},[161,162],80.92313,26.83928,{"lat":162,"lon":161},{"facility":165,"status":46,"city":166,"state":167,"zip":168,"country":147,"countryCode":148,"cosmosGeoPoint":169,"geoPoint":173,"contacts":41},"Institute of Child Health","Kolkata","West Bengal","700017",{"type":53,"coordinates":170},[171,172],88.36304,22.56263,{"lat":172,"lon":171},{"facility":175,"status":46,"city":176,"state":177,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":41},"Hospital Germans Trias i Pujol","Badalona","Barcelona [barcelona]","08916","Spain","ES",{"type":53,"coordinates":182},[183,184],2.24741,41.45004,{"lat":184,"lon":183},{"facility":187,"status":46,"city":188,"state":177,"zip":189,"country":179,"countryCode":180,"cosmosGeoPoint":190,"geoPoint":194,"contacts":41},"Hospital Sant Joan de Déu","Esplugues de Llobregat","08950",{"type":53,"coordinates":191},[192,193],2.08809,41.37732,{"lat":193,"lon":192},{"facility":196,"status":46,"city":197,"state":198,"zip":199,"country":179,"countryCode":180,"cosmosGeoPoint":200,"geoPoint":204,"contacts":41},"Hospital Universitario La Paz","Madrid","Madrid, Comunidad de","28046",{"type":53,"coordinates":201},[202,203],-3.70256,40.4165,{"lat":203,"lon":202},{"facility":206,"status":46,"city":207,"state":41,"zip":208,"country":179,"countryCode":180,"cosmosGeoPoint":209,"geoPoint":213,"contacts":41},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"type":53,"coordinates":210},[211,212],2.15899,41.38879,{"lat":212,"lon":211},{"facility":215,"status":46,"city":197,"state":41,"zip":216,"country":179,"countryCode":180,"cosmosGeoPoint":217,"geoPoint":219,"contacts":41},"Hospital Universitario 12 de Octubre","28041",{"type":53,"coordinates":218},[202,203],{"lat":203,"lon":202},{"facility":221,"status":46,"city":222,"state":222,"zip":223,"country":224,"countryCode":225,"cosmosGeoPoint":226,"geoPoint":230,"contacts":41},"Hsinchu Municipal Mackay Children's Hospital","Hsinchu","300046","Taiwan","TW",{"type":53,"coordinates":227},[228,229],120.96861,24.80361,{"lat":229,"lon":228},{"facility":232,"status":46,"city":233,"state":41,"zip":234,"country":224,"countryCode":225,"cosmosGeoPoint":235,"geoPoint":239,"contacts":41},"National Taiwan University Hospital","Taipei","100225",{"type":53,"coordinates":236},[237,238],121.52639,25.05306,{"lat":238,"lon":237},{"facility":241,"status":46,"city":242,"state":41,"zip":243,"country":224,"countryCode":225,"cosmosGeoPoint":244,"geoPoint":248,"contacts":41},"Chang Gung Medical Foundation-Linkou Branch","Taoyuan","333",{"type":53,"coordinates":245},[246,247],121.29696,24.99368,{"lat":247,"lon":246},{"facility":250,"status":251,"city":252,"state":253,"zip":254,"country":255,"countryCode":41,"cosmosGeoPoint":41,"geoPoint":41,"contacts":41},"Cukurova Universty","ACTIVE_NOT_RECRUITING","Sarçam","Adana","01250","Turkey (Türkiye)",{"facility":257,"status":251,"city":258,"state":259,"zip":260,"country":255,"countryCode":41,"cosmosGeoPoint":261,"geoPoint":265,"contacts":41},"Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi","Istanbul","İ̇stanbul","34093",{"type":53,"coordinates":262},[263,264],28.94966,41.01384,{"lat":264,"lon":263},{"type":267,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","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":279,"type":280},48,"ESTIMATED","INTERVENTIONAL",[283],"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.",[286],"Gram-negative Bacterial Infections",[288],"Gram-negative bacterial infections","2026-06-29",{"date":291,"type":292},"2026-07-01","ACTUAL",{"date":294,"type":292},"2023-04-18",{"date":296,"type":280},"2027-03-31",{"name":5,"class":6},23]