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Last Updated: 10/31/2025
A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT
Summary: The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights ...
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Summary: Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the app...
A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION
Summary: 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 ...
Ceftazidime Plus Fosfomycin Versus Ceftazidime Alone for Severe Gram-negative Infections: a Triple-blind, Placebo-controlled Point-of-care Randomized Clinical Trial
Summary: The goal of this clinical trial is to : 1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time to normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and reduction in C-reactive protein (CRP) compared to standard of care (CAZ±AVI alone) 2....
Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial
Summary: This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies 1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count? 2. Are there any specific factors that affect how children with hematologica...
Randomized Trial to Study the Effect of Rifaximin on Gut Microbiome Diversity Post Allogeneic Stem Cell Transplant in Acute Leukemia.
Objective: To determine the impact of rifaximin on gut microbial diversity and compare it with controls. * Secondary
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With Pseudomonas Aeruginosa in Adults With Bronchiectasis: a Non-inferiority Randomized Controlled Trial.
Summary: Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ra...
Comparative Analysis of Delirium in Older Patients Treated With Selected Antibiotics: a Prospective Cohort Study
Summary: The goal of this observational study is to learn if the use of ceftazidime, cefepime, and ceftriaxone impacts the incidence of delirium in elderly patients (aged 65 and older) with infections. The main questions it aims to answer are: Does the administration of these antibiotics increase the incidence of delirium in elderly patients? How do renal and hepatic dose adjustments affect the likelihood ...
Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia
Summary: This randomised controlled trial will determine the non-inferiority of stopping empiric antibiotics prior to absolute neutrophil count (ANC) recovery (Early Stopping) versus stopping antibiotics upon ANC recovery (Standard of Care/ Late Stopping) , in children with cancer and high-risk febrile neutropenia (FN).
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
Summary: The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treati...
Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Summary: Ceftazidime avitbatan sodium is a broad-spectrum antibiotic with an antimicrobial spectrum covering resistant gram-negative bacteria. Its use in pediatric intensive care for severe infections is not unusual. Pathophysiological changes in severe sepsis can lead to significant changes in pharmacokinetics and pharmacodynamics during continuous renal replacement therapy.This research aims to study cha...
Early Discontinuation of Antibiotics for Unexplained Febrile Neutropenia: a Pilot Randomized Controlled Trial- EASE ANTIBIOTICS Pilot Trial
Summary: Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population. Patients with cancer and low neutrophil counts due to chemotherapy or disease often have a fever and receive antibiotic treatment. The optimal duration of this treatment is largely unknown. Late, there have been some data suggesting the safety of early discontin...
Last Updated: 10/31/2025