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

NCT ID: NCT04546815

Last Updated: 2020-09-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2022-08-31

Brief Summary

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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

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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

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Antibiotic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun J Ren, master

Role: CONTACT

18205138967 ext. 18205138967

XiaoJun X Ma, doctor

Role: CONTACT

13911378823 ext. 13911378823

Facility Contacts

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XiaoJun X Ma, doctor

Role: primary

+86 13911378823 ext. 13911378823

Jun J Ren, master

Role: backup

+86 18205138967 ext. 18205138967

Other Identifiers

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SINGCHN-DAP-IV-2002

Identifier Type: -

Identifier Source: org_study_id

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