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

Recruiting now · Phase 2

Conditions studied: Gram-negative Bacterial Infection

In brief

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.

Key facts

Study ID

NCT06462235

Run by

Pfizer

People needed

48

Starts

2024-09-25

Expected to finish

2027-04-25

Last updated by the study team

2026-06-11

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
• 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.
• Participants with any of the following characteristics/conditions will be excluded:
• 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.

Where it is running

• Children's Hospital of Orange County Southwest Tower — Orange, California, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• Norton Children's Hospital — Louisville, Kentucky, United States (enrolling)
• Novak Center for Children's Health — Louisville, Kentucky, United States (enrolling)
• University of Louisville, Norton Children's Research Institute — Louisville, Kentucky, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Duke University - Main Hospital and Clinics — Durham, North Carolina, United States (enrolling)
• Memorial Hermann Hospital - Texas Medical Center — Houston, Texas, United States (enrolling)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
• Sanatorio Sagrado Corazón — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Clinica Del Niño Y La Madre — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Clinica Privada del Sol S.A — Córdoba, Córdoba Province, Argentina (enrolling)
• Hospital del Niño Jesús — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Nirmal Hospital Pvt Ltd. — Surat, Gujarat, India (enrolling)
• RajaRajeswari Medical College and Hospital — Bengaluru, Karnataka, India (enrolling)
• Sahyadri Super Speciality Hospital — Pune, Maharashtra, India (enrolling)
• Medanta Hospital Lucknow — Lucknow, Uttar Pradesh, India (enrolling)
• Institute of Child Health — Kolkata, West Bengal, India (enrolling)
• Schneider Children's Medical Center — Petah Tikva, Central District, Israel (enrolling)
• Rambam Health Care Campus — Haifa, Northern District, Israel (enrolling)
• Hsinchu Municipal Mackay Children's Hospital — Hsinchu, Hsinchu, Taiwan (enrolling)
• Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — Hualien City, Hualien, Taiwan (enrolling)
• Taichung Veterans General Hospital — Taichung, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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