A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
NCT ID: NCT06462235
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2024-09-25
2028-07-31
Brief Summary
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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.
Detailed Description
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Participants in Part A must be hospitalized and receiving intravenous antibiotic treatment for a suspected or confirmed bacterial infection. Participants will receive a single 3 hour intravenous infusion of ATM-AVI and have 3 ATM-AVI blood level assessments during and up to 5 hour after the infusion. Participants will be observed for 48 hours following the infusion to assess safety and toleration and will have a final follow-up safety assessment which may be conducted by telephone 4-5 weeks following the infusion. The single infusion of ATM-AVI is administered to assess the safety, tolerability, and pharmacokinetics of a single dose of ATM-AVI and is not intended as treatment for the bacterial infection. The total duration of study participation in Part A is expected to be 5 weeks through the end of the final safety follow-up.
Participants in Part B must be hospitalized with suspected or confirmed aerobic gram-negative bacterial infection requiring intravenous antibacterial therapy. Part B participants will receive multiple 3 hour intravenous infusions of ATM-AVI every 6 hour (8 hours for preterm infants) for 3-14 days as treatment for their bacterial infection and to assess ATM-AVI pharmacokinetics, safety, tolerability, and efficacy. Participants with complicated intra-abdominal infection (cIAI) will also receive intravenous metronidazole and all participants will have the option to receive other intravenous antibiotic treatment for gram-positive bacteria, as appropriate. Participants who have a good clinical response after 72 hours of intravenous ATM-AVI treatment may be switched to a different orally administered antibiotic, if clinically appropriate. Part B participants will have a total of 5 ATM-AVI blood level assessments over the first 2 or more days following the start of ATM-AVI infusions and will have their clinical response assessed at the End of Treatment (intravenous and oral, if applicable), and at a Test-of-Cure (TOC) evaluation 7 to 14 days after the last antibiotic treatment (intravenous or oral). A final safety assessment which may be conducted by telephone will occur 4-5 weeks after the last dose of ATM-AVI. The total duration of study participation in Part B is expected to be up to 7 weeks through the end of the final safety follow-up.
Additional safety monitoring will be provided by an independent external Data Monitoring Committee (DMC). Enrollment for the study will begin with Part A, single dose, cohorts 1-3. Part A Cohort 4 (preterm neonates) will commence enrollment after sponsor and DMC review of plasma drug levels and safety for a least 2 participants in Part A Cohort 3 and review of ATM-AVI safety and tolerability for all participants enrolled at that time. Enrollment in the multidose Part B cohorts will be delayed until preliminary information is obtained regarding ATM-AVI multidose safety, tolerability, and drug levels for the participants 9 months to 2 years of age in the separate ongoing ATM-AVI pediatric study C3601008 \[NCT05639647\].
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Part A, Cohorts 1-4
Single dose pharmacokinetics.
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, Cohorts 1-4
Multi-dose pharmacokinetics and treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
39 Weeks
ALL
No
Sponsors
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AbbVie
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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 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
Hsinchu Municipal Mackay Children's Hospital
Hsinchu, Hsinchu, Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-507757-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CHERISH
Identifier Type: OTHER
Identifier Source: secondary_id
C3601010
Identifier Type: -
Identifier Source: org_study_id