Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections

Serious Gram-positive Infections Clinical Trial

Official title:

Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01314053
• Other study ID #: 99084
• Status: Active, not recruiting
• Phase: N/A
• First received: March 10, 2011
• Last updated: March 10, 2011
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: March 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Daptomycin was approved since 2005 in Taiwan and have been studied and published in west countries. After review the published papers, the few data were described in the Asian countries or Taiwan. The objectives of this study are to evaluate the efficacy and safety of daptomycin for the treatment of Gram-positive infections under actual conditions of use, and to understand other information concerned with daptomycin prescription. This study represents an opportunity for acquiring real world data on daptomycin usage, and may provide physicians in Taiwan with the information of characteristic of the patients receiving daptomycin and to evaluate outcomes. It also provides a means to identify safety signals that emerge with clinical usage.

Description:

This is a retrospective, non-comparative study, which will be performed after obtaining permission from the institutional review board. Patients with serious gram-positive infections who had received daptomycin from January 2009 and completed daptomycin therapy by the end of December 2010 will be screened, and patients who received ≥ 3 days of daptomycin will be identified eligible to be included. Eligible patients' medical records will be reviewed.

As this is a retrospective chart review, it is expected that informed consent will not be necessary. For patients' confidentiality concern, patients' name or chart number will not to be record in any part of Data Collection Form (APPENDIX 1). A patient identification number will be assigned to each patient included in this surveillance. A study coordinator at site will be identified, and hospital specific process will be utilized to identify patients. Information to be collected was shown on Data Collection Form (Appendix 1). After completing patient data collection, the efficacy and safety will be evaluated for the included cases.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients started daptomycin therapy since January 2009.

• Patients completed daptomycin therapy by the end of December 2010.

• Patients had Gram positive infections.

• Patients received daptomycin therapy for at least 3 days.

Exclusion Criteria:

• Daptomycin therapy will be chosen by the treating physician based on clinical indication and it is expected that risks of therapy will have already been considered.

• subjects are only to be excluded if he/she was enrolled in any antibiotics clinical trial during daptomycin treatment.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Serious Gram-positive Infections

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan,