NCT00428818

Brief Summary

Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become more prevalent than infections with β-lactam susceptible bacteria. This has necessitated altered empiric antimicrobial therapy of SSTI to cover MRSA. Objective: To evaluate empiric therapy with trimethoprim-sulfamethoxazole or doxycycline for outpatient SSTI in an area of high MRSA prevalence. Design: Randomized, prospective, open-label investigation. Setting: Emergency Department of Parkland Hospital in Dallas, Texas. Patients: Adults with SSTI. Intervention: Empiric oral therapy with trimethoprim-sulfamethoxazole (160 mg/800 mg, twice daily) or doxycycline (100 mg, twice daily). Measurement: The primary endpoint was clinical failure defined as hospitalization or change in antibiotic therapy over the 10 to 14 days after initial emergency department evaluation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2005

Status
completed

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

Study Start

First participant enrolled

August 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
Last Updated

January 30, 2007

Status Verified

January 1, 2007

First QC Date

January 29, 2007

Last Update Submit

January 29, 2007

Conditions

Infection

Keywords

MRSA

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint was clinical failure defined as hospitalization or change in antibiotic therapy over the 10 to 14 days after initial emergency department evaluation.

Interventions

trimethoprim-sulfamethoxazole or doxycyclineDRUG

Eligibility Criteria

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

You may qualify if:

  • Outpatient treatment of SSTI abscesses, requiring wound packing after incision and drainage but not requiring hospitalization.
  • Adults (≥ 18 years old) who were willing and able to provide informed consent.
  • Able to return for follow-up at 2 to 5 days after enrollment and being accessible by telephone for follow-up assessment at 10 to 14 days and 28 to 35 days after enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug CombinationDoxycycline

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Robert D Hardy, MD

    University of Texas Southwestern Medical Center

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

August 1, 2005

Study Completion

July 1, 2006

Last Updated

January 30, 2007

Record last verified: 2007-01