Condition: Gram-negative Bacterial Infections · Sponsor: Pfizer
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. The study is seeking participants who are: * 9 months to less than 18 years of age * Hospitalized * Suspected/known to have a gram-negative infection * Receiving intravenous (iv, given directly into a vein) antibiotics * Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs. * Participants will receive either ATM-AVI or best available therapy (BAT). * Both therapies will be given through a vein. * 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. * The iv dose of ATM-AVI will be based on the participant's weight and kidney function. * The study doctor will determine the iv dose of BAT. * During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. * Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. * Participants will receive a maximum of 14 days of ATM-AVI treatment. * After discharge from the hospital, 1 study visit ma…
This description comes directly from the study's public registry record.
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| Rady Children's Hospital | San Diego, California, United States | Recruiting |
| Weill Cornell Medicine-New York Presbyterian Hospital | New York, New York, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
| Beijing Children's Hospital, Capital Medical University | Beijing, Beijing Municipality, China | Recruiting |
| Guangzhou Women and Children's Medical Center | Guangzhou, Guangdong, China | Recruiting |
| Shanghai Children's Medical Center | Shanghai, China | Recruiting |
| University General Hospital of Heraklion | Heraklion, Irakleío, Greece | Recruiting |
| Ippokrateio General Hospital of Thessaloniki | Thessaloniki, Kentrikí Makedonía, Greece | Recruiting |
| Semmelweis Egyetem | Budapest, Hungary | Recruiting |
| Semmelweis Egyetem | Budapest, Hungary | Recruiting |
| RajaRajeswari Medical College and Hospital | Bangalore, Karnataka, India | Recruiting |
| Medanta Hospital Lucknow | Lucknow, Uttar Pradesh, India | Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05639647