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

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 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.

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. 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 it's running

• Children's Hospital of Orange County Southwest Tower
  Orange, California, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Riley Hospital for Children at Indiana University Health
  Indianapolis, Indiana, United States Recruiting
• Norton Children's Hospital
  Louisville, Kentucky, United States Recruiting
• Novak Center for Children's Health
  Louisville, Kentucky, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Different dosing schedules of ceftazidime‑avibactam plus aztreonam for carbapenem‑resistant Gram‑negative infections

  This trial tests different dosing schedules of ceftazidime‑avibactam plus aztreonam to see which works best for adults with metallo‑β‑lactamase–producing, carbapenem‑resistant Gram‑negative infections.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjin, Jiangsu · NCT07478484

• Feireqing Granules added to standard care for severe pneumonia from resistant Gram-negative infections

  This trial tests whether Feireqing Granules, used with standard treatment, can help adults with severe pneumonia caused by drug-resistant Gram-negative bacteria.

  Recruiting Henan University of Traditional Chinese Medicine · Zhengzhou, Henan · NCT07206745

• Evaluating Fluorothiazinone for Preventing Bacterial Infections in Ventilated Patients

  This study is testing if a new drug called Fluorothiazinone can help prevent bacterial infections in patients on ventilators in the ICU.

  Recruiting at 2 sites Phase 2 Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Moscow, Moscow and 1 other locations · NCT06135350

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

  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.

  Recruiting at 20 sites Phase 2 Pfizer · San Diego, California and 21 other locations · NCT05639647

• Predicting Death in ICU Patients with Multidrug-Resistant Gram-Negative Infections

  This study tests whether a Mortality risk model can predict outcomes for critically ill adults in the ICU who are colonized or infected with multidrug-resistant Gram-negative bacteria.

  Recruiting Fundacion SEIMC-GESIDA · Madrid, Madrid · NCT07749508

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.