NCT00713674

Brief Summary

The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Status
withdrawn

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

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

July 7, 2008

Last Update Submit

March 21, 2017

Conditions

Methicillin-Resistant Staphylococcus Aureus

Keywords

Methicillin resistance

Outcome Measures

Primary Outcomes (1)

  • Evidence of decolonization confirmed by intranasal culture

    Up to 14 days post treatment (+/- 1-2 days)

Secondary Outcomes (1)

  • Economic-Cost comparison of treatment Evidence of decolonization

    5 days of treatment

Study Arms (3)

1

NO INTERVENTION

No Treatment

2

EXPERIMENTAL

Theraworx intranasal

Other: Theraworx

3

ACTIVE COMPARATOR

mupirocin antibiotic ointment intranasal

Drug: mupirocin antibiotic ointment

Interventions

TheraworxOTHER

Theraworx swab intranasal BID for 5 days

2
mupirocin antibiotic ointmentDRUG

mupirocin antibiotic ointment swab intranasal BID for 5 days

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive MRSA culture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Roger E Huckfeldt, MD

    Mercy/St. John's Hospital - Springfield

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 11, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 23, 2017

Record last verified: 2017-03