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

Recruiting now · Phase 2

Conditions studied: Gram-negative Bacterial Infections

In brief

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.

Key facts

Study ID: NCT05639647
Run by: Pfizer
People needed: 48
Starts: 2023-04-18
Expected to finish: 2027-03-31
Last updated by the study team: 2026-07-01

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
Participants ≥9 months to <18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (β hCG sensitivity ≥25 mIU/mL).
Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
Require hospitalization and IV antibiotic treatment.

You may not qualify if…

Participants with any of the following characteristics/conditions will be excluded:
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Gram-negative species not expected to respond to ATM AVI ≤14 days.
Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.
(HAP/VAP only):
Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant.
Received >24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.
Current use of any prohibited concomitant medication(s) or unwilling/unable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer).
CrCL ≤15 mL/min/1.73 m2 (eCrCl or eGFR calculation based on age).
Non-infectious related screening ALT or AST >3 x ULN, ALP >3 x ULN and/or TBili >2 x ULN (> 3 x ULN for Gilbert's syndrome).
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Where it is running

Rady Children's Hospital — San Diego, California, United States (enrolling)
Weill Cornell Medicine-New York Presbyterian Hospital — New York, New York, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Beijing Children's Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (enrolling)
Shanghai Children's Medical Center — Shanghai, China (enrolling)
University General Hospital of Heraklion — Heraklion, Irakleío, Greece (enrolling)
Ippokrateio General Hospital of Thessaloniki — Thessaloniki, Kentrikí Makedonía, Greece (enrolling)
Semmelweis Egyetem — Budapest, Hungary (enrolling)
Semmelweis Egyetem — Budapest, Hungary (enrolling)
RajaRajeswari Medical College and Hospital — Bangalore, Karnataka, India (enrolling)
Medanta Hospital Lucknow — Lucknow, Uttar Pradesh, India (enrolling)
Institute of Child Health — Kolkata, West Bengal, India (enrolling)
Hospital Germans Trias i Pujol — Badalona, Barcelona [barcelona], Spain (enrolling)
Hospital Sant Joan de Déu — Esplugues de Llobregat, Barcelona [barcelona], Spain (enrolling)
Hospital Universitario La Paz — Madrid, Madrid, Comunidad de, Spain (enrolling)
Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
Hsinchu Municipal Mackay Children's Hospital — Hsinchu, Hsinchu, Taiwan (enrolling)
National Taiwan University Hospital — Taipei, Taiwan (enrolling)
Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan (enrolling)
Cukurova Universty — Sarçam, Adana, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi — Istanbul, İ̇stanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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