Real-world Daptomycin Use in Chinese ICUs

July 22, 2022 updated by: Xuelian Liao, West China Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who are suspected of Gram-positive infection in the Intensive Care Units.

Description

Inclusion Criteria:

  • Patient who received at least one dose of daptomycin

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study population
Patient who receive at least one dose of daptomycin
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days
death
30 days
Cure Rate
Time Frame: 30 days
clinical and microbiological effectiveness
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 30 days
organ dysfunction，allergy，creatine kinase levels，eosinophilic pneumonia，etc.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HX 00147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intensive Care Unit

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe