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

Hengrui Medicine

Status: Unknown

Conditions: Antibiotic

Treatments: Drug: Daptomycin

Study type: Observational

Funder types: Industry

Identifiers

NCT04546815

SINGCHN-DAP-IV-2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1 years of age or older

• Meet one of the following conditions:

  1. Confirmed Gram-positive cocci (GPC) infection;
  2. Cases evaluated by doctors as suspected gram-positive coccal infection with potentially high benefit from drug use；
  3. Severe infection patients to be combined with empirical treatment of daptomycin.

• The off-label drug use conforms to the relevant administrative regulations of each participating unit.

Exclusion criteria

• Allergic to datoramycin;
• Pregnant and lactating women；
• Patients with age < 1 year；
• Participate in other clinical trials；
• Patients with nervous system GPC infection;
• Patients with pulmonary GPC infection.

Trial design

2,000 participants in 1 patient group

Gram-positive cocci infection

Description:

No intervention. The clinical data of patients (including demographic information, details of anti-infective therapy, imaging and laboratory testings) will be collected and analyzed.

Treatment:

Drug: Daptomycin