Sepsis Clinical Trial
Official title:
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae: the Study of in Vitro Activity of Monotherapy and Combination Therapy, PK/PD Study and Treatment Outcomes
The purpose of this study is to evaluate the treatment outcomes in patients with CRE infections.
Antibiotic resistance is one of the major problems because of global burden. Resistant
pathogens are non-susceptible to available antibiotics, causing of high clinical mortality
(clinical impact) and high budget (economic impact), whereas new antibiotics in drug
development are fewer. Carbapenem-Resistant Enterobacteriaceae (CRE) are categorized into one
of the critical groups in World Health Organization's lists. In Thailand, the spread of CRE
have been risen continuously since 2011.
Diverse actions are designed to address antibiotic resistance with limited resources, known
as antimicrobial stewardship programs (ASPs). Dose-optimization by using PK/PD
(Pharmacokinetics/Pharmacodynamics) application is recommendation of supplemental strategies
in clinical routine practice. The benefit of the strategy is to reduce inappropriate
antibiotic use and provide minimum resistance as well as maximum the success of clinical
treatment.
Antibiotic combination regimens have a role for the CRE treatment. However, current evidence
in clinical study is not concluded which the best or optimal combined antibiotics are. The
reasons may be that combined antibiotics often vary among different sites of infection,
causative pathogens, the patterns of local antimicrobial susceptibility and patient
comorbidity. As the results, the antibiotic combination regimens for the treatment any
infections caused by CRE is needed for further investigation. The anticipated result is to
fill the limited data of the appropriate antibiotic regimens for individual Thai patients.
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