Home › Trials › NCT06462235

Evaluating Aztreonam-Avibactam for Treating Bacterial Infections in Infants and Newborns

A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT

PHASE2 · Pfizer · NCT06462235

This study is testing a new antibiotic combination to see if it is safe and effective for treating bacterial infections in hospitalized infants and newborns.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment48 (estimated)
AgesN/A to 39 Weeks
SexAll
SponsorPfizer (industry)
Locations29 sites (Orange, California and 28 other locations)
Trial IDNCT06462235 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effects of a combination antibiotic, aztreonam-avibactam (ATM-AVI), in hospitalized infants and newborns with bacterial infections caused by gram-negative bacteria. The study is divided into two parts: Part A involves a single intravenous infusion of ATM-AVI to evaluate safety and pharmacokinetics, while Part B consists of multiple infusions for confirmed infections. Participants will be closely monitored for safety and tolerability during and after the treatment. The study will enroll a total of 48 participants across four age cohorts, ensuring a comprehensive evaluation of the treatment's effects in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized infants and newborns up to 9 months old who are receiving intravenous antibiotics for suspected or confirmed bacterial infections.

Not a fit: Patients with severe renal impairment or those who have received other investigational products recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing serious bacterial infections in infants and newborns.

How similar studies have performed: While this approach is novel in this specific population, similar studies have shown promise in treating bacterial infections with combination antibiotics.

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. 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.

Where this trial is running

Orange, California and 28 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 →

Conditions: Gram-negative Bacterial Infection, gram-negative, aztreonam-avibactam, neonate, infant

Last reviewed 2026-05-15 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.