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
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2020
CompletedFirst Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedSeptember 17, 2020
September 1, 2020
1.9 years
August 26, 2020
September 15, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
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: 1. After the end of the treatment, all the symptoms and signs of the patients at the time of inclusion continued or worsened. 2. Recurrence. 3. 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 Outcomes (4)
Bacteria clearance rate (if available, such as bacteremia)
1 day of the end of treatment
The overall incidence of adverse events
14 days of the end of treatment
Monitor creatine phosphokinase（CPK） levels
14 days of the end of treatment
hospital stays
28 days of the end of treatment
Study Arms (1)
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.
Interventions
According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.
Eligibility Criteria
The study plans to recruit 2000 patients infected with gram-positive bacteria.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
XiaoJun X Ma, doctor
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 14, 2020
Study Start
August 25, 2020
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
September 17, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
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.