NCT00903279

Brief Summary

The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 31, 2017

Status Verified

May 1, 2009

First QC Date

May 14, 2009

Last Update Submit

January 30, 2017

Conditions

Orthopedic ProceduresMethicillin-resistant Staphylococcus Aureus

Keywords

MRSA colonizationOrthopedic SurgeryAltabaxPlacebo

Outcome Measures

Primary Outcomes (1)

  • Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization

    30 days

Secondary Outcomes (1)

  • Identify a predominant clone among the MRSA isolates in this study

    2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Altabax

EXPERIMENTAL
Drug: Altabax (retapamulin)

Interventions

PlaceboDRUG

Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.

Placebo
Altabax (retapamulin)DRUG

Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.

Also known as: Retapamulin
Altabax

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are admitted for an orthopedic surgical procedure
  • All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA

You may not qualify if:

  • Pregnancy
  • Serious systemic illness due to renal, cardiac or hepatic disease
  • Inability to complete follow-up assessments
  • Allergy or intolerance to retapamulin
  • BMI \> 30
  • Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
  • Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
  • Antibiotics administered during the course of the study will be recorded (name, dose and dates)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bay Pines VAHCS

Bay Pines, Florida, 33744, United States

Location

MeSH Terms

Interventions

retapamulin

Study Officials

  • Suzane Silbert, PhD

    Bay Pines VAHCS

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

August 1, 2009

Study Completion

December 1, 2010

Last Updated

January 31, 2017

Record last verified: 2009-05

Locations

US(1)