NCT04546815

The Efficacy and Safety of Daptomycin in the Treatment of Gram-positive Bacterial Infection.

Non-interventional Observational Study of Daptomycin in the Treatment of Gram-positive Bacterial Infections

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Jiangsu Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This study aims to collect and analyze clinical data of daptomycin to explore the efficacy and safety of daptomycin in the treatment of Gram-positive bacterial infections. And optimize the dosing regimen based on these data.

Detailed description

With the gradual increase in the detection rate of drug-resistant bacteria, bloodstream infections, skin and soft tissue infections, infective endocarditis and other infectious diseases caused by MRSA, MRCNS, and VRE have greatly increased patient mortality and medical burden. Daptomycin has strong anti-bacterial activity and rapid sterilization. It is almost 100% sensitive to common Gram-positive bacteria. Both domestic and foreign guidelines recommend its use for the treatment of infectious diseases such as bacteremia, central venous catheter-related bloodstream infections, infective endocarditis, skin and soft tissue infections, bone and joint infections，and so on. However, there is a lack of actual clinical use of daptomycin in China, as well as efficacy and safety assessments based on real world data. The purpose of this study is to collect and analyze data on the use of daptomycin in the real world. The clinical cure rate and inefficiency, temperature drop time, 28-day mortality rate are the primary outcome measures, and the overall incidence of adverse events, the results of CPK monitoring and its correlation with dose, renal function, length of hospital stay, and treatment costs are secondary outcome measures to investigate the efficacy and safety of daptomycin in the treatment of gram-positive bacterial infection.

Conditions

• Antibiotic

Interventions

Type	Name	Description
DRUG	Daptomycin	According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.

Timeline

• Start date: 2020-08-25
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2020-09-14
• Last updated: 2020-09-17

Locations

1 site across 1 country: China