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

RecruitingPhase 2Ages 9 Months - 17 YearsAllPfizer
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1. 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). 2. Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens. 3. Require hospitalization and IV antibiotic treatment. Exclusion Criteria Participants with any of the following characteristics/conditions will be excluded: 1. 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. 2. Gram-negative species not expected to respond to ATM AVI ≤14 days. 3. 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): 4. 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. 5. 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. 6. 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). 7. CrCL ≤15 mL/min/1.73 m2 (eCrCl or eGFR calculation based on age). 8. 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). 9. 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.
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What it tests

  • ATM-AVI
  • BAT
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Where

23 sites
Rady Children's Hospital
San Diego, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, United States
Icahn School of Medicine at Mount Sinai
New York, United States
Beijing Children's Hospital, Capital Medical University
Beijing, China
Guangzhou Women and Children's Medical Center
Guangzhou, China
Shanghai Children's Medical Center
Shanghai, China
University General Hospital of Heraklion
Heraklion, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Greece

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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