A5041616368- Antibiotics Pharmacokinetics and Efficacy
- Pneumonia and Respiratory Infections
- Antibiotic Resistance in Bacteria
- Cystic Fibrosis Research Advances
- Fungal Infections and Studies
- Antifungal resistance and susceptibility
- Urinary Tract Infections Management
- Nail Diseases and Treatments
- Bacterial Infections and Vaccines
- Liver physiology and pathology
- Pharmaceutical studies and practices
- Poisoning and overdose treatments
- Antimicrobial Resistance in Staphylococcus
- Drug Transport and Resistance Mechanisms
- Optical Imaging and Spectroscopy Techniques
- Antibiotic Use and Resistance
- Functional Brain Connectivity Studies
- Nematode management and characterization studies
- Drug-Induced Hepatotoxicity and Protection
- Hemodynamic Monitoring and Therapy
- Neonatal Health and Biochemistry
- Clinical Nutrition and Gastroenterology
- Reproductive tract infections research
- Organ Transplantation Techniques and Outcomes
- Advanced MRI Techniques and Applications
National Institute of Allergy and Infectious Diseases
2021-2025
National Institutes of Health
2022-2025
Beijing University of Technology
2023
Emisphere Technologies (United States)
2009
ABSTRACT This Phase 1 trial described the intrapulmonary pharmacokinetics and safety profile of IV fosfomycin in healthy participants . Fosfomycin, a broad-spectrum antibiotic mainly used to treat urinary tract infections, is being considered for treatment more complex conditions, including lung due emergence multidrug-resistant (MDR) organisms. Despite its potential, intravenous (IV) fosfomycin, particularly penetration into lower respiratory tract, are unknown. To address this gap, we...
Objectives: Piperacillin, a β-lactam antibiotic, and tazobactam, β-lactamase inhibitor, combine to offer broad antibacterial coverage with low toxicity. This combination is first-line treatment for severe infections in critically ill patients. Given the significant pharmacokinetic (PK) variability caused by complex pathophysiological changes patients, identifying effective dosing regimens of piperacillin-tazobactam this special population imperative [1]. To address clinical need, study aims...
Objective: Antimicrobial resistance (AMR) poses a significant global health threat, especially with pathogens like the ESKAPE group, known for causing severe infections, including pneumonia, lower respiratory tract infection (1). Fosfomycin has been reported to treat such kind of resistant (2) and is rapidly penetrate lungs (3). Due these facts, NIH conducted phase 1 clinical study on fosfomycin (ZTI-01). Thirty healthy participants were given 6 g dose every 8 hours via IV infusion. Blood...
Scant pharmacokinetic (PK) data are available on ceftazidime-avibactam (CZA) and aztreonam (ATM) in combination, it is unknown if CZA-ATM exacerbates alanine aminotransferase (ALT)/aspartate (AST) elevations relative to ATM alone. This phase 1 study sought describe the PK of assess associations between exposures ALT/AST elevations.
In the present study, population pharmacokinetic (PK) analysis was performed based on meropenem data from a prospective study conducted in 114 critically ill patients with wide range of renal functions and various disease conditions. The final model one-compartment linear elimination, creatinine clearance continuous replacement therapy affecting clearance, total bodyweight impacting volume distribution. Our is valuable addition to existing PK models, it could be particularly useful during...
VT-1598 is a novel fungal CYP51 inhibitor and 1-tetrazole-based antifungal drug candidate with improved selectivity minimizing off-target binding to inhibition of human CYP450 enzymes. Data are presented from this first clinical study in the evaluation safety pharmacokinetic (PK) single ascending doses 40, 80, 160, 320, 640 mg VT-1598, comprising 160 cohort both fasting fed states. Eight healthy adults per dose were randomized receive either oral or placebo (3:1). Over range, exposures...
We aimed to identify rational empirical dosing strategies for cefepime treatment in critically ill patients by utilizing population pharmacokinetics and target attainment analysis.
Rezafungin is a novel echinocandin being developed for the treatment and prevention of invasive fungal infections. The objectives this randomized, double-blind study in healthy adults were to determine safety, tolerability, pharmacokinetics rezafungin after subcutaneous (s.c.) administration. design consisted six sequential cohorts eight subjects, except first cohort with four subjects. subjects randomized 3:1 ratio placebo receive single dose 1, 10, 30, 60, 100, or 200 mg. most common...
Zoliflodacin is a novel spiropyrimidinetrione antibiotic being developed as single oral dose treatment to address the growing global threat of Neisseria gonorrhoeae. To evaluate cardiac safety zoliflodacin, thorough QT/QTc (TQT) study was performed in healthy subjects. In this randomized, double-blind, placebo-controlled, 4-period crossover study, 72 subjects fasted state received zoliflodacin at 2 g (therapeutic), 4 (supratherapeutic), placebo, and moxifloxacin 400 mg positive comparator....
Patients with cystic fibrosis (CF) experience recurrent bacterial pulmonary exacerbations. Management of these infections is increasingly challenging due to decreased antimicrobial susceptibility β-lactam antibiotics. The pharmacokinetics (PK) agents are inadequately characterized in patients CF. This study enrolled 155 pediatric and adult participants CF who were receiving the following antibiotics: cefepime (n = 82), meropenem 42), or piperacillin-tazobactam 31). Opportunistic blood...
To investigate which independent factor(s) have an impact on the pharmacokinetics of vancomycin in critically ill children, develop equation to predict 24-hour area under concentration-time curve from a trough concentration, and evaluate dosing regimens likely achieve minimum inhibitory concentration ratio (AUC24/MIC) greater than or equal 400.
Abstract Determining an effective dosing regimen for piperacillin–tazobactam in critically ill patients is challenging due to substantial pharmacokinetic variability caused by complex pathophysiological changes. To address this need, a prospective clinical study was conducted, which enrolled 112 and employed opportunistic sampling strategy. Population modeling simulation were performed characterize the pharmacokinetics (PK) probability of target attainment (PTA) under various regimens. Both...
Abstract Background Patients with cystic fibrosis (CF) experience recurrent bacterial pulmonary exacerbations. The management of these infections becomes increasingly complex due to decreased antimicrobial susceptibility and inadequate pharmacokinetic/pharmacodynamic (PK/PD) characterization the most commonly used agents in this population. Methods One hundred fifty-five pediatric adult participants receiving cefepime (n=82), meropenem (n=42), or piperacillin-tazobactam (n=31) were enrolled....
Abstract Background Scant PK data are available with CZA-ATM in combination. Occurrence of ALT/AST elevations common ATM, and it is unknown if exacerbated by use CZA-ATM. This analysis COMBINE sought to describe the popPK assess association between ATM exposures elevations. Methods was a Phase I study 48 healthy subjects aged 18-45 years (NCT03978091). Subjects were enrolled into 1 6 Cohorts (Table 1). Drug(s) administered for 7 D intensive plasma urine sampling performed. PopPK models...
Abstract Background Patients with cystic fibrosis (CF) experience recurrent bacterial pulmonary exacerbations. The management of these infections becomes increasingly complex due to decreased antimicrobial susceptibility and inadequate pharmacokinetic/pharmacodynamic (PK/PD) characterization the most commonly used agents in this population. Methods One hundred fifty-five pediatric adult participants receiving cefepime (n=82), meropenem (n=42), or piperacillin-tazobactam (n=31) were enrolled....