NCT01049438

Brief Summary

This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Status
completed

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

August 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

3.1 years

First QC Date

January 13, 2010

Last Update Submit

January 13, 2010

Conditions

Methicillin Resistant Staphylococcus Aureus Skin Infections

Keywords

MRSAMethicillin Resistant Staphylococcus aureusStaphylococcus aureusSkin InfectionsBody Decolonization

Outcome Measures

Primary Outcomes (1)

  • A new MRSA or skin infection consistent with MRSA infection.

    6 months

Study Arms (1)

Nasal, body, and systemic decolonization

EXPERIMENTAL
Drug: nasal mupirocinDrug: topical 3% hexachlorophene body washDrug: oral anti-MRSA antibiotic

Interventions

nasal mupirocinDRUG

twice daily for 10 days

Also known as: Bactrban Nasal
Nasal, body, and systemic decolonization
topical 3% hexachlorophene body washDRUG

daily for 10 days

Also known as: Phisohex
Nasal, body, and systemic decolonization
oral anti-MRSA antibioticDRUG

The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient

Also known as: trimethoprim-sulfamethoxazole, doxycycline, minocycline
Nasal, body, and systemic decolonization

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Staphylococcal InfectionsCellulitis

Interventions

TriclosanTrimethoprim, Sulfamethoxazole Drug CombinationDoxycyclineMinocycline

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesSulfanilamidesAniline CompoundsAminesSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Allen Radner, M.D.

    Navidad Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

August 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 14, 2010

Record last verified: 2010-01