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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Antibiotic

Intervention / Treatment
-----------------
* Drug: Daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 years of age or older Meet one of the following conditions: Confirmed Gram-positive cocci (GPC) infection; Cases evaluated by doctors as suspected gram-positive coccal infection with potentially high benefit from drug use； 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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gram-positive cocci infection<br>No intervention. The clinical data of patients (including demographic information, details of anti-infective therapy, imaging and laboratory testings) will be collected and analyzed. | Drug: Daptomycin<br>* According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy rate | Clinical efficacy includes clinical cure and clinical improvement. | 1 day of the end of treatment | 
| 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 | 
| 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 | 
| Time for body temperature to return to normal. | During the use of daptomycin, take body temperature records. | 14 days of the end of treatment | 
| 28-Day Mortality Rate | Record the number of deaths 28 days after the end of treatment | 28 days of the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Monitor creatine phosphokinase（CPK） levels | Record the CPK monitoring results. | 14 days of the end of treatment | 
| hospital stays |  | 28 days of the end of treatment |