NCT00388310

Brief Summary

To evaluate the effective duration (in days) to clinical improvement of outpatient antibiotic regimens in the treatment of superficial abscesses caused by MRSA in patients that present to the emergency department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

October 13, 2006

Last Update Submit

November 7, 2012

Conditions

Keywords

cellulitisfurunclescarbunclesabscess

Outcome Measures

Primary Outcomes (2)

  • To determine the effective duration of treatment of different antibiotic regimens in the treatment of abscess with regards to resolution of patient symptoms and signs.

    5 days

  • Treatment failure will be defined as an increase in patient symptoms, increase in abscess size, development of constitutional symptoms, or hospitalization secondary to abscess complications

    5 days

Study Arms (4)

Cephalexin

ACTIVE COMPARATOR

Cephalexin 250 mg PO q6h x5 days

Procedure: Culture

Clindamycin

ACTIVE COMPARATOR

Clindamycin 300 mg PO q6h x5 days

Procedure: Culture

trimethoprim/sulfamethoxazole

ACTIVE COMPARATOR

trimethoprim/sulfamethoxazole 160 mg/800 mg PO q12h x 5 days

Procedure: Culture

Placebo

PLACEBO COMPARATOR
Procedure: Culture

Interventions

CulturePROCEDURE

Culture

CephalexinClindamycinPlacebotrimethoprim/sulfamethoxazole

Eligibility Criteria

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

You may qualify if:

  • All patients age 18 and older, presenting to the emergency department with an abscess with a diameter greater than three centimeters
  • Informed consent

You may not qualify if:

  • Patients who are presumed to have community-acquired pathogens
  • Under 18
  • Abscess less than three centimeters in diameter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Skin Diseases, InfectiousCellulitisFurunculosisCarbuncleAbscess

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue DiseasesSuppurationConnective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsStaphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSkin Diseases, BacterialFish DiseasesAnimal Diseases

Intervention Hierarchy (Ancestors)

In Vitro TechniquesInvestigative Techniques

Study Officials

  • Brian Levine, MD

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 16, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations