Condition: Gram-negative Bacterial Infection · Sponsor: Pfizer
The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections. The study will include newborns and infants up to 9 months of age who are admitted in the hospital. The study is conducted in 2 parts: Part A and Part B. In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount. In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.
This description comes directly from the study's public registry record.
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| Children's Hospital of Orange County Southwest Tower | Orange, California, United States | Recruiting |
| Children's Hospital of Orange County | Orange, California, United States | Recruiting |
| Children's Hospital Colorado | Aurora, Colorado, United States | Recruiting |
| Riley Hospital for Children at Indiana University Health | Indianapolis, Indiana, United States | Recruiting |
| Norton Children's Hospital | Louisville, Kentucky, United States | Recruiting |
| Novak Center for Children's Health | Louisville, Kentucky, United States | Recruiting |
| University of Louisville, Norton Children's Research Institute | Louisville, Kentucky, United States | Recruiting |
| Tufts Medical Center | Boston, Massachusetts, United States | Recruiting |
| Duke University - Main Hospital and Clinics | Durham, North Carolina, United States | Recruiting |
| Memorial Hermann Hospital - Texas Medical Center | Houston, Texas, United States | Recruiting |
| The University of Texas Health Science Center at Houston | Houston, Texas, United States | Recruiting |
| Sanatorio Sagrado Corazón | Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06462235