The Efficacy and Safety of Daptomycin in the Treatment of Gram-positive Bacterial Infection.
NCT ID: NCT04546815
Last Updated: 2020-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2020-08-25
2022-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Gram-positive cocci infection
No intervention. The clinical data of patients (including demographic information, details of anti-infective therapy, imaging and laboratory testings) will be collected and analyzed.
Daptomycin
According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.
Interventions
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Daptomycin
According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
ALL
No
Sponsors
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Jiangsu Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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XiaoJun X Ma, doctor
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SINGCHN-DAP-IV-2002
Identifier Type: -
Identifier Source: org_study_id
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