Actively Recruiting
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
Led by Pfizer · Updated on 2026-05-05
48
Participants Needed
29
Research Sites
134 weeks
Total Duration
On this page
Sponsors
P
Pfizer
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized infants from birth to less than 9 months old, including preterm babies
- Part A: Receiving intravenous antibiotics for suspected or confirmed bacterial infection (such as complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia, bloodstream infection, or sepsis)
- Part B: Suspected or confirmed gram-negative bacterial infection requiring intravenous antibiotics (including the conditions listed above)
You will not qualify if you...
- Received any other investigational medicine within 30 days or 5 half-lives before enrollment
- Any medical or laboratory abnormality that increases risks or is judged inappropriate by the investigator
- Severe kidney impairment or known significant kidney disease, shown by high serum creatinine, low urine output for 6 hours, or need for dialysis
- Part B only: Received more than 24 hours of systemic antibiotics for gram-negative bacteria at enrollment unless there is documented treatment failure or no improvement after 48 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Children's Hospital of Orange County Southwest Tower
Orange, California, United States, 92868
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
Novak Center for Children's Health
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
University of Louisville, Norton Children's Research Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
8
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
9
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
10
Rutgers University
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
11
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States, 27710
Actively Recruiting
12
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
13
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
14
Sanatorio Sagrado Corazón
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1039
Actively Recruiting
15
Clinica Del Niño Y La Madre
Mar del Plata, Buenos Aires, Argentina, 7600
Not Yet Recruiting
16
Clinica Privada del Sol S.A
Córdoba, Córdoba Province, Argentina, X5000IIH
Actively Recruiting
17
Hospital del Niño Jesús
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
18
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India, 395002
Actively Recruiting
19
RajaRajeswari Medical College and Hospital
Bengaluru, Karnataka, India, 560074
Actively Recruiting
20
Medanta Hospital Lucknow
Lucknow, Uttar Pradesh, India, 226030
Actively Recruiting
21
Institute of Child Health
Kolkata, West Bengal, India, 700017
Actively Recruiting
22
Schneider Children's Medical Center
Petah Tikva, Central District, Israel, 49202
Actively Recruiting
23
Rambam Health Care Campus
Haifa, Northern District, Israel, 3109601
Actively Recruiting
24
Clalit Health Services through Schneider Children's Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
25
Hsinchu Municipal Mackay Children's Hospital
Hsinchu, Hsinchu, Taiwan, 300046
Actively Recruiting
26
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Hualien, Taiwan, 970
Actively Recruiting
27
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Actively Recruiting
28
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
29
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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