A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
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
- Gram-negative Bacterial Infection
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 48
- Started
- 25 September 2024
- Main results due
- 25 April 2027
- Study sites
- 30
- Registry updated
- 24 September 2026
Can you take part?
- Up to 39 weeks.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(30)
Children's Hospital of Orange County Southwest Tower
Orange, California, United States
Recruiting
Children's Hospital of Orange County
Orange, California, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Recruiting
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Recruiting
Norton Children's Hospital
Louisville, Kentucky, United States
Recruiting
Novak Center for Children's Health
Louisville, Kentucky, United States
Recruiting
University of Louisville, Norton Children's Research Institute
Louisville, Kentucky, United States
Recruiting
Tufts Medical Center
Boston, Massachusetts, United States
Recruiting
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
Recruiting
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States
Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Recruiting
Sanatorio Sagrado Corazón
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Clinica Del Niño Y La Madre
Mar del Plata, Buenos Aires, Argentina
Recruiting
Clinica Privada del Sol S.A
Córdoba, Córdoba Province, Argentina
Recruiting
Hospital del Niño Jesús
San Miguel de Tucumán, Tucumán Province, Argentina
Recruiting
UMHAT Deva Maria
Burgas, Bulgaria
Recruiting
Umhat Kanev
Rousse, Bulgaria
Recruiting
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
Recruiting
RajaRajeswari Medical College and Hospital
Bengaluru, Karnataka, India
Recruiting
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Recruiting
Medanta Hospital Lucknow
Lucknow, Uttar Pradesh, India
Recruiting
Institute of Child Health
Kolkata, West Bengal, India
Recruiting
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
Recruiting
Rambam Health Care Campus
Haifa, Northern District, Israel
Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Florence, Italy
Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Not yet recruiting
Hsinchu Municipal Mackay Children's Hospital
Hsinchu, Hsinchu, Taiwan
Recruiting
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Hualien, Taiwan
Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan
Recruiting
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Recruiting
Showing 30 of 30 sites. 28 of the 30 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06462235. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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