NCT03588637

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

2.6 years

First QC Date

June 20, 2018

Last Update Submit

July 22, 2022

Conditions

DaptomycinReal-world StudyIntensive Care Unit

Outcome Measures

Primary Outcomes (2)

  • mortality

    death

    30 days

  • Cure Rate

    clinical and microbiological effectiveness

    30 days

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events

    30 days

Study Arms (1)

Study population

Patient who receive at least one dose of daptomycin

Other: No intervention

Interventions

No interventionOTHER

No intervention

Study population

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patient who received at least one dose of daptomycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 17, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2021

Study Completion

December 30, 2021

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

CN(1)