A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

Conditions

• Gram-negative Bacterial Infection

Eligibility Criteria

Sex

ALL

Age

N/A - 39 Weeks

Healthy Volunteers

Not accepted

Interventions

• Part A: ATM-AVI Single Dose, Cohorts 1-4 — DRUG
  Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration.
• Part B: Multiple-dose ATM-AVI, Cohorts 1-4 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Sep 25, 2024

Status verified

Jun 2026

Primary completion

Apr 25, 2027

Completion

Apr 25, 2027

Study Design

Enrollment

48 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Part A, Cohorts 1-4
  Single dose pharmacokinetics.
• Experimental: Part B, Cohorts 1-4
  Multi-dose pharmacokinetics and treatment

Primary Outcome Measure

Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI [ Time Frame: Up to Day 15 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (11)

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