Actively Recruiting

Phase 2
Age: 9Months - 17Years
All Genders
NCT05639647

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

Led by Pfizer · Updated on 2026-05-14

48

Participants Needed

24

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 participant safety and effects in pediatric participants. The study is seeking participants 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 that includes the abdomen, urinary tract, blood stream, and lungs. * Participants 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). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 9Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 9 months to less than 18 years at screening
  • Female participants who have started menstruating must have a negative pregnancy test
  • Suspected or confirmed complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired or ventilator-associated pneumonia, or bloodstream infection involving gram-negative bacteria
  • Require hospitalization and intravenous antibiotic treatment
Not Eligible

You will not qualify if you...

  • Medical or psychiatric conditions that increase risk or make participation unsafe
  • Infection with gram-negative bacteria not expected to respond to ATM-AVI treatment for 14 days or more
  • Pregnant or breastfeeding participants
  • Fertile males or females unwilling or unable to use effective contraception for specified periods after last ATM-AVI dose
  • For pneumonia participants: known or likely monomicrobial gram-positive infection, lung abscess, pleural empyema, post-obstructive pneumonia, or lung/heart transplant
  • More than 24 hours of systemic antibiotics within 48 hours before randomization unless documented treatment failure
  • Current use of prohibited medications or unwilling/unable to use Metronidazole; patients with Cockayne Syndrome and complicated intra-abdominal infection excluded
  • Creatinine clearance less than 15 mL/min/1.73 m2
  • Abnormal liver function tests beyond specified limits
  • Investigator site staff involved in the study and their family members, or sponsor employees involved in the study and their family members

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 24 locations

1

Rady Children's Hospital

San Diego, California, United States, 92123

Actively Recruiting

2

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, United States, 10021

Actively Recruiting

3

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

4

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

5

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100045

Not Yet Recruiting

6

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China, 510623

Not Yet Recruiting

7

Shanghai Children's Medical Center

Shanghai, China, 200127

Actively Recruiting

8

University General Hospital of Heraklion

Heraklion, Irakleío, Greece, 715 00

Actively Recruiting

9

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, Greece, 546 42

Actively Recruiting

10

Semmelweis Egyetem

Budapest, Hungary, 1083

Actively Recruiting

11

Semmelweis Egyetem

Budapest, Hungary, 1094

Actively Recruiting

12

RajaRajeswari Medical College and Hospital

Bangalore, Karnataka, India, 560074

Actively Recruiting

13

Medanta Hospital Lucknow

Lucknow, Uttar Pradesh, India, 226030

Actively Recruiting

14

Institute of Child Health

Kolkata, West Bengal, India, 700017

Actively Recruiting

15

Hospital Germans Trias i Pujol

Badalona, Barcelona [barcelona], Spain, 08916

Actively Recruiting

16

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [barcelona], Spain, 08950

Actively Recruiting

17

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain, 28046

Actively Recruiting

18

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

19

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

20

Hsinchu Municipal Mackay Children's Hospital

Hsinchu, Taiwan, 300046

Actively Recruiting

21

National Taiwan University Hospital

Taipei, Taiwan, 100225

Actively Recruiting

22

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan, 333

Actively Recruiting

23

Cukurova Universty

Sarçam, Adana, Turkey (Türkiye), 01250

Active, Not Recruiting

24

Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi

Istanbul, İ̇stanbul, Turkey (Türkiye), 34093

Active, Not Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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