Clinical trial NCT04546815: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic
Lead sponsor: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study plans to recruit 2000 patients infected with gram-positive bacteria.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical efficacy rate
timeFrame: 1 day of the end of treatment
measure: Clinical cure rate
timeFrame: 14 days of the end of treatment
measure: Treatment failure rate
timeFrame: 28 days of the end of treatment
measure: Time for body temperature to return to normal.
timeFrame: 14 days of the end of treatment
measure: 28-Day Mortality Rate
timeFrame: 28 days of the end of treatment
Secondary outcomes:
measure: Bacteria clearance rate (if available, such as bacteremia)
timeFrame: 1 day of the end of treatment
measure: The overall incidence of adverse events
timeFrame: 14 days of the end of treatment
measure: Monitor creatine phosphokinase（CPK） levels
timeFrame: 14 days of the end of treatment
measure: hospital stays
timeFrame: 28 days of the end of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: XiaoJun X Ma, doctor
role: PRINCIPAL_INVESTIGATOR
References: