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A Study to Learn About the Study Medicine Called Aztreonam-Avibactam in Neonates and Infants Less Than 9 Months of Age With Suspected or Confirmed Infections Due to Gram-Negative Bacteria
EU CTIS ID: 2023-507757-15-01
What this study is testing
Evaluate the PK of ATM-AVI for the treatment of gram-negative bacterial infections including complicated urinary tract infection (cUTI), complicated intraabdominal infection (cIAI), hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP), blood stream infection (BSI), or sepsis in hospitalized neonates and infants from birth to <9 month of age. Evaluate the safety and tolerability of ATM-AVI in hospitalized neonates and infants from birth to <9 months.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Hospitalized with age from birth <9 months, including preterm birth
- Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
- Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
You likely can't join if
- Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
- Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output <0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis.
- Part B Only: Received >24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom of infection after ≥48 hours of antibiotics.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- India
- United States
- Israel
- Argentina
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; India; United States; Israel; Argentina; Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.