NCT06462235 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pfizer |
| Condition | Gram-negative Bacterial Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2027-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2024-09-25 with a primary completion date of 2027-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06462235 clinical trial?
This trial is open to participants of all sexes, up to 39 Weeks, studying Gram-negative Bacterial Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06462235 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06462235 currently recruiting?
Yes, NCT06462235 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06462235 trial being conducted?
This trial is being conducted at Orange, United States, Orange, United States, Aurora, United States, Indianapolis, United States and 11 additional locations.
Who is sponsoring the NCT06462235 clinical trial?
NCT06462235 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 48 participants.