Comparison of Decolonization of Methicillin-resistant Sta... | NCT00713674

Studies
Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx

NCT00713674

Sponsor

Mercy Research

Status

Withdrawn

Last Update Posted

Mar 23, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Methicillin-Resistant Staphylococcus Aureus

Interventions

Theraworx
mupirocin antibiotic ointment

Countries

Not provided

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of patient recruitment.

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jul 7, 2008

First Submission Date that Met QC Criteria

Jul 10, 2008

First Posted Date

Jul 11, 2008Estimated

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

Mar 21, 2017

Last Update Posted Date

Mar 23, 2017Actual

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 examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.

Detailed Description

Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	No Treatment
2	Experimental	Theraworx intranasal	Other: Theraworx
3	Active Comparator	mupirocin antibiotic ointment intranasal	Drug: mupirocin antibiotic ointment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Theraworx	Other	Theraworx swab intranasal BID for 5 days	2
mupirocin antibiotic ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of decolonization confirmed by intranasal culture		Up to 14 days post treatment (+/- 1-2 days)

Secondary Outcomes

Measure	Description	Time Frame
Economic-Cost comparison of treatment Evidence of decolonization		5 days of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive MRSA culture

Exclusion Criteria:

Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
Patients with MRSA infected wounds
Patients under the age of 18 years
A woman currently pregnant or nursing a child
Patients participating in another study within 30 days of randomization

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roger E Huckfeldt, MD	Mercy/St. John's Hospital - Springfield	Principal Investigator

Locations

Not provided