Safety and Efficacy Study of CUBICIN (Daptomycin) Under C... | NCT01219114

Studies
Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use

NCT01219114

Sponsor

AstraZeneca

Status

Withdrawn

Last Update Posted

Sep 28, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis

Interventions

Not provided

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to recruit patients within the specified time period. No patients have been enrolled in the study.

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Oct 10, 2010

First Submission Date that Met QC Criteria

Oct 10, 2010

First Posted Date

Oct 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2011

Last Update Posted Date

Sep 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events observed during the treatment duration		Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)
Clinical Response determined by cure rate		Ranges from during treatment and up to 14 days after last administration of daptomycin

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
Prescribed daptomycin by patient's attending physician

Exclusion Criteria:

Known allergic or serious adverse reaction to daptomycin
Patients with pneumonia
Patients with baseline CPK values >1000 U/L or 5x ULN

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

several private and government tertiary hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milagros Tan, MD	AstraZeneca Philippines	Study Director
Emmanuel Arca, MD	AstraZeneca Philippines	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lipa City	Batangas		Philippines
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D004696	Endocarditis

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided