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

Recruiting Phase 2 Interventional Study
Gram-negative Bacterial Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
9 Months – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Pfizer · Industry
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About This Trial
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, give…
Trial Locations
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Eligibility Criteria
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/…
Contacts

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

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