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A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

NCT06462235

RecruitingPhase 2

Sponsor: Pfizer

Conditions: Gram-negative Bacterial Infection

Interventions: Part A: ATM-AVI Single Dose, Cohorts 1-4, Part B: Multiple-dose ATM-AVI, Cohorts 1-4

Countries: United States, Argentina, India, Israel, Taiwan

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.

Eligibility overview

Sex: ALL

Age: — to 39 Weeks

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

1. Hospitalized with age from birth \<9 months, including preterm birth
2. 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.
3. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.

Participants with any of the following characteristics/conditions will be excluded:

1. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
2. 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.
3. 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.
4. 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.

Locations (26)

Orange, California, United States
Orange, California, United States
Aurora, Colorado, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Durham, North Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Córdoba, Córdoba Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Surat, Gujarat, India
Bengaluru, Karnataka, India
Pune, Maharashtra, India
Lucknow, Uttar Pradesh, India
Kolkata, West Bengal, India
Petah Tikva, Central District, Israel
Haifa, Northern District, Israel
Hsinchu, Hsinchu, Taiwan
Hualien City, Hualien, Taiwan
Taichung, Taiwan
Taoyuan, Taiwan