NCT00829686

Brief Summary

Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.

Trial Health

87
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 Jun 2008

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

June 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 28, 2009

Completed
Last Updated

June 9, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

January 26, 2009

Results QC Date

June 5, 2009

Last Update Submit

May 10, 2017

Conditions

Abscess

Keywords

abscesscellulitisantibioticsMRSA

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement at 7 Days After Incision and Drainage

    improving wound without evidence of fever, worsening cellulitis or induration

    7 days

Secondary Outcomes (1)

  • Recurrence Rates

    30 days

Study Arms (2)

No intervention

NO INTERVENTION

No antibiotic

Septra DS

ACTIVE COMPARATOR

Septra DS (800/160) two pills PO BID x 7 days

Drug: Septra

Interventions

SeptraDRUG

(800/125) PO BID X 7 days

Septra DS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.

You may not qualify if:

  • patients with diabetes, HIV, cancer or other immunocompromised patients
  • patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables
  • pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment
  • basic Military Trainees will also be excluded from participation
  • patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded
  • patients with sulfa allergy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Location

MeSH Terms

Conditions

AbscessCellulitis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsSkin Diseases, InfectiousConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Gillian Schmitz, MD
Organization
Wilford Hall Medical Center
gillianmd@gmail.com
919-724-9185

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

June 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 9, 2017

Results First Posted

July 28, 2009

Record last verified: 2017-05

Locations

US(1)