Comparing Aztreonam and Avibactam to Standard Therapy for Serious Infections in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of two medications, Aztreonam and Avibactam, in pediatric patients hospitalized with serious gram-negative bacterial infections. Participants aged 9 months to less than 18 years will be randomly assigned to receive either the new treatment or the best available therapy. The study will involve multiple sites and will include four age cohorts, ensuring a comprehensive assessment of the treatment across different pediatric age groups. The goal is to gather data on how these medications are processed in children and their overall safety.

Why it matters

Who can join: the full rules

Inclusion Criteria

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

1. Participants ≥9 months to \<18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (β hCG sensitivity ≥25 mIU/mL).
2. Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
3. Require hospitalization and IV antibiotic treatment.

Exclusion Criteria

Participants with any of the following characteristics/conditions will be excluded:

1. 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.
2. Gram-negative species not expected to respond to ATM AVI ≤14 days.
3. Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.

   (HAP/VAP only):
4. 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.
5. Received \>24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.
6. Current use of any prohibited concomitant medication(s) or unwilling/unable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer).
7. CrCL ≤15 mL/min/1.73 m2 (eCrCl or eGFR calculation based on age).
8. Non-infectious related screening ALT or AST \>3 x ULN, ALP \>3 x ULN and/or TBili \>2 x ULN (\> 3 x ULN for Gilbert's syndrome).
9. 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.

Where it's running

• Rady Children's Hospital
  San Diego, California, United States Recruiting
• Weill Cornell Medicine-New York Presbyterian Hospital
  New York, New York, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• Beijing Children's Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Recruiting
• Shanghai Children's Medical Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.