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

A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION

Phase 2 Interventional Pfizer · NCT05639647

This study is testing if two new medications, Aztreonam and Avibactam, can help children with serious bacterial infections feel better compared to the usual treatments they receive.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment48 (estimated)
Ages9 Months to 17 Years
SexAll
SponsorPfizer Industry-sponsored
Locations24 sites (San Diego, California and 23 other locations)
Trial IDNCT05639647 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are hospitalized children aged 9 months to less than 18 years with suspected or confirmed gram-negative infections requiring intravenous antibiotics.

Not a fit: Patients with gram-negative infections not expected to respond to the treatment within 14 days or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for serious gram-negative infections in children.

How similar studies have performed: While there have been studies on treatments for gram-negative infections, this specific combination of Aztreonam and Avibactam in pediatric patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

San Diego, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gram-negative Bacterial InfectionsGram-negative bacterial infections
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.