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NCT06462235 · ClinicalTrials.gov registry record · Phase 2
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 2 study of Gram-negative Bacterial Infection, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT06462235: Recruiting Phase 2 study of Gram-negative Bacterial Infection, sponsored by Pfizer.
NCT06462235 is a Phase 2 study of Gram-negative Bacterial Infection that is actively recruiting participants, run by Pfizer. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06462235, a Phase 2 study of Gram-negative Bacterial Infection, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts.
Conditions Studied
Interventions
- DRUG Part A: ATM-AVI Single Dose, Cohorts 1-4
- DRUG Part B: Multiple-dose ATM-AVI, Cohorts 1-4
Study Locations (20)
Kentucky
- Norton Children's Hospital - Louisville
- Novak Center for Children's Health - Louisville
- University of Louisville, Norton Children's Research Institute - Louisville
California
- Children's Hospital of Orange County Southwest Tower - Orange
- Children's Hospital of Orange County - Orange
New Jersey
- Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital - New Brunswick
- Rutgers University - New Brunswick
Texas
- Memorial Hermann Hospital - Texas Medical Center - Houston
- The University of Texas Health Science Center at Houston - Houston
Buenos Aires
- Sanatorio Sagrado Corazón - Ciudad Autónoma de Buenos Aires
- Clinica Del Niño Y La Madre - Mar del Plata
Colorado
- Children's Hospital Colorado - Aurora
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2027-12-02 |
| Phase | Phase 2 |
What NCT06462235 shows while recruiting
NCT06462235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Gram-negative Bacterial Infection appearing as the primary indexed condition, and to 2 interventions - of which Part A: ATM-AVI Single Dose, Cohorts 1-4 is the first listed.
NCT06462235 names 20 study sites across 14 states, led by Kentucky, California, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06462235 about?
NCT06462235 is a clinical study titled "A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)". 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 u...
What is the current status of trial NCT06462235?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2024-09-25. Estimated completion is 2027-12-02.
What conditions does trial NCT06462235 study?
This clinical trial studies the following conditions: Gram-negative Bacterial Infection.
What interventions are being tested in trial NCT06462235?
The interventions under investigation include: Part A: ATM-AVI Single Dose, Cohorts 1-4 (DRUG), Part B: Multiple-dose ATM-AVI, Cohorts 1-4 (DRUG).
Who is sponsoring clinical trial NCT06462235?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06462235 being conducted?
This trial has 20 study locations across California, Colorado, Indiana, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06462235's enrollment target sits among peer trials
48 1265th of 2000 higher than 719 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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