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

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

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.

Study Overview

• Status: Unknown
• Conditions: Antibiotic
• Intervention / Treatment: Drug: Daptomycin

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: XiaoJun X Ma, doctor; Phone Number: 13911378823 13911378823; Email: xjma@public.bta.net.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: XiaoJun X Ma, doctor; Phone Number: 13911378823 +86 13911378823; Email: xjma@public.bta.net.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study plans to recruit 2000 patients infected with gram-positive bacteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Daptomycin; According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.

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

Collaborators and Investigators

• Sponsor: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: XiaoJun X Ma, doctor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 6, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Gram-Positive Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Daptomycin
• Other Study ID Numbers: SINGCHN-DAP-IV-2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The clinical study data of this project were owned by the participating research center. For other researchers who need data, the results of the study can be understood through the literature published later.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No