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NCT03588637 Clinical Trial

Real-world Daptomycin Use in Chinese ICUs

Intensive Care Unit Clinical Trial

Official title:
Real-world Effectiveness and Safety on Daptomycin in Gram-Positive Infections in Chinese Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03588637
Other study ID # HX 00147
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 30, 2021

Study information
Verified date July 2022
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Analyze the effectiveness and safety of Daptomycin(Jiangsu Hengrui Medicine Co., Ltd) in Gram-positive infections in Chinese Intensive Care Units by using the real-world data platform, https://rws.scccmqc.com. Patients who received at least one dose of Daptomycin between 2016 to 2021 are eligible.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 30, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 100 Years
Eligibility Inclusion Criteria: - Patient who received at least one dose of daptomycin Exclusion Criteria: - No

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality death 30 days
Primary Cure Rate clinical and microbiological effectiveness 30 days
Secondary Number of participants with treatment-related adverse events organ dysfunction,allergy,creatine kinase levels,eosinophilic pneumonia,etc. 30 days
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