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

Antibiotic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546815
• Other study ID #: SINGCHN-DAP-IV-2002
• Status: Recruiting
• Start date: August 25, 2020
• Est. completion date: August 2022

Study information

• Verified date: September 2020
• Source: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Contact: Jun J Ren, master
• Phone: 18205138967
• Email: renjun8967[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic
• Bacterial Infections
• Gram-Positive Bacterial Infections

Intervention

Drug:
• Daptomycin
According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy rate	Clinical efficacy includes clinical cure and clinical improvement.	1 day of the end of treatment
Primary	Clinical cure rate	Clinical cure was defined as that after the end of treatment, all the selected symptoms and signs had disappeared or completely returned to normal, and all the non-microbiological indicators, such as imaging and laboratory examination, had returned to normal.	14 days of the end of treatment
Primary	Treatment failure rate	Treatment failure includes one of the following conditions: After the end of the treatment, all the symptoms and signs of the patients at the time of inclusion continued or worsened.; Recurrence.; Termination of treatment due to adverse reactions.	28 days of the end of treatment
Primary	Time for body temperature to return to normal.	During the use of daptomycin, take body temperature records.	14 days of the end of treatment
Primary	28-Day Mortality Rate	Record the number of deaths 28 days after the end of treatment	28 days of the end of treatment
Secondary	Bacteria clearance rate (if available, such as bacteremia)	Bacterial clearance includes clearance and hypothetical clearance. Bacterial clearance is defined as the specimens from the original infection site after treatment have not cultivated the pathogenic bacteria of the original infection.; When the patient's symptoms and signs disappear so that cultivable materials cannot be obtained, or the method of obtaining specimens is too invasive for the recovered patient, the bacteriological result is considered to be a hypothetical clearance.	1 day of the end of treatment
Secondary	The overall incidence of adverse events	Adverse events refer to adverse medical events that occur after patients or clinical trial subjects receive a drug, but they do not necessarily have a causal relationship with treatment.	14 days of the end of treatment
Secondary	Monitor creatine phosphokinase(CPK) levels	Record the CPK monitoring results.	14 days of the end of treatment
Secondary	hospital stays		28 days of the end of treatment