Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
Sponsor: Pfizer
Summary
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.
Official title: A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT
Key Details
Gender
All
Age Range
Any - 39 Weeks
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-09-25
Completion Date
2027-12-02
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Part A: ATM-AVI Single Dose, Cohorts 1-4
Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration.
Part B: Multiple-dose ATM-AVI, Cohorts 1-4
Multiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy.
Locations (30)
Children's Hospital of Orange County Southwest Tower
Orange, California, United States
Children's Hospital of Orange County
Orange, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Novak Center for Children's Health
Louisville, Kentucky, United States
University of Louisville, Norton Children's Research Institute
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers University
New Brunswick, New Jersey, United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Sanatorio Sagrado Corazón
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Clinica Del Niño Y La Madre
Mar del Plata, Buenos Aires, Argentina
Clinica Privada del Sol S.A
Córdoba, Córdoba Province, Argentina
Hospital del Niño Jesús
San Miguel de Tucumán, Tucumán Province, Argentina
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
RajaRajeswari Medical College and Hospital
Bengaluru, Karnataka, India
Medanta Hospital Lucknow
Lucknow, Uttar Pradesh, India
Institute of Child Health
Kolkata, West Bengal, India
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Clalit Health Services through Schneider Children's Medical Center
Petah Tikva, Israel
Hsinchu Municipal Mackay Children's Hospital
Hsinchu, Hsinchu, Taiwan
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Hualien, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, Taiwan