Actively Recruiting
A Phase 2a Multicenter, Observer-Blinded, Randomized Study to Investigate Pharmacokinetics, Safety, and Efficacy of Intravenous Aztreonam-Avibactam Compared to Best Available Therapy in Pediatric Participants with Serious Gram-Negative Bacterial Infections
Led by Pfizer · Updated on 2026-06-05
48
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the medicines Aztreonam (ATM) and Avibactam (AVI) are processed in children and teenagers aged 9 months to less than 18 years who are hospitalized with serious gram-negative bacterial infections. The study aims to assess the safety and effects of these medicines compared to the best available therapy (BAT) in treating complicated infections of the abdomen, urinary tract, bloodstream, and lungs. This phase 2a, multicenter, observer-blinded, randomized trial includes participants with suspected or confirmed infections requiring intravenous antibiotics. Participants will be randomly assigned to receive either ATM-AVI or BAT through a vein. ATM-AVI dosing is adjusted based on weight and kidney function and is given every 6 or 8 hours, infused over 3 hours, with treatment lasting up to 14 days. Those with complicated abdominal infections may also receive intravenous Metronidazole (MTZ), except for participants with Cockayne Syndrome due to risk of liver damage. Some participants may switch to oral therapy as decided by the study doctor. The study includes four age cohorts, with ongoing safety and pharmacokinetic data reviews to adjust doses as needed. During the study, participants will have multiple blood samples taken to analyze drug levels and clearance. A blinded observer will assess daily safety and adverse events while hospitalized and during follow-up visits. The study tracks clinical response, liver and kidney function, and potential side effects up to 50 days. After hospital discharge, one study visit and phone check-ins will monitor participants' health. The total study duration ranges from 33 to 50 days depending on individual response.
CONDITIONS
Brief 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
- 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 with gram-negative bacteria
- Hospitalized and require intravenous antibiotic treatment
You will not qualify if you...
- Having other medical or psychiatric conditions that increase risk or make participation inappropriate
- Infection with gram-negative bacteria not expected to respond to Aztreonam-Avibactam for at least 14 days
- Pregnant or breastfeeding, or unwilling/unable to use effective contraception after treatment
- For pneumonia: infection likely caused by gram-positive bacteria, lung abscess, pleural empyema, post-obstructive pneumonia, or lung/heart transplant
- Received more than 24 hours of systemic antibiotics in the 48 hours before randomization unless treatment failure is documented
- Current use of prohibited medications or unwilling/unable to use Metronidazole
- Severe kidney impairment with creatinine clearance less than or equal to 15 mL/min/1.73 m2
- Significant liver enzyme abnormalities or bilirubin elevation beyond set limits
- Investigator site staff, their family members, and sponsor staff involved in the study and their family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive intravenous Aztreonam-Avibactam or best available therapy for serious gram-negative bacterial infections. Treatment may last up to 14 days depending on response, with an option to switch to oral therapy after 3 days. Daily clinical assessments by a blinded observer occur while hospitalized.
Daily clinical assessments during hospitalization
Duration - Up to 36 days after treatment
Participants are assessed for safety and efficacy after treatment ends, including evaluation of adverse events and test of cure within 7 to 14 days after the last antibiotic treatment.
1 to 2 visits within 7 to 14 days after treatment
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, 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
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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