Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections

• Status: Not yet recruiting
• Trial end date: 2025-12-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand their safety and effects in pediatric participants. The study is seeking people who are:

• 9 months to less than 18 years of age

• Hospitalized

• Suspected/known to have a gram-negative infection

• Receiving intravenous (iv, given directly into a vein) antibiotics

• Being treated for complicated infections of various body parts. These include the abdomen, urinary tract, blood stream, and lungs.

Everyone taking part will receive either ATM-AVI or best available therapy (BAT). Both therapies will be given through a vein. Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion. The iv dose of ATM-AVI will be based on the participant's weight and kidney function. The study doctor will determine the iv dose of BAT. During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. Participants will receive a maximum of 14 days of ATM-AVI treatment.

After discharge from the hospital, 1 study visit may be required. Depending on the participant's response, the study duration will be from 33 to 50 days. The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Avibactam; Aztreonam

Criteria

Inclusion Criteria:

• Participants aged greater or equal to 9 months to less than 18 years at screening

• Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens

• Require hospitalization and IV antibiotic treatment

Exclusion Criteria:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

• Gram-negative species not expected to respond to ATM AVI within 14 days

• Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at greater than or equal to 7 days (males) or greater or equal to 28 days (females) after last ATM-AVI infusion.

• HAP/VAP only: Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant.

• Received >24 hours of systemic antibiotics (abx) for less than or equal to 48hr before randomization, except if;

• Failed systemic abx for >48hr.

• Not taking protocol prohibited medications, Section

• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

• Creatinine clearance (CrCL) less than or equal to 15 mL/min/1.73 m^2 (estimated glomerular filtration (eGFR) calculation based on age).

• Non-infectious related screening ALT or AST greater than 3 x upper limit of normal (ULN), ALP greater than 3 x ULN and/or total bilirubin (TBili) greater than 2 x ULN (> 3 x ULN for Gilbert's syndrome)

• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.