NCT04516395

Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the treatment outcomes in patients with CRE infections.

Detailed description

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.

Conditions

• Drug Resistance
• Carbapenem-Resistant Enterobacteriaceae Infection
• Sepsis
• Septic Shock
• Critical Illness
• Clinical Outcomes
• Treatment Outcomes

Interventions

Type	Name	Description
OTHER	Combined antibiotic regimens	Combined antibiotic combinations defined as the optimal antibiotic combination regimens which are created from in vitro study and the application of PK/PD.
OTHER	Standard antibiotic regimens	Standard antibiotic regimens defined as the antibiotic regimens which are generally given to the patients following to the hospital protocol.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-03-01
• Completion: 2021-04-01
• First posted: 2020-08-18
• Last updated: 2020-08-26

Locations

1 site across 1 country: Thailand