Actively Recruiting
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
Eligibility Criteria
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
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
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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