NCT00973765

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) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 2, 2010

Completed
Last Updated

March 9, 2010

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

September 8, 2009

Results QC Date

January 19, 2010

Last Update Submit

March 1, 2010

Conditions

Abscesses

Keywords

abcessMRSAcellulitisantibioticsuncomplicated abscesses

Outcome Measures

Primary Outcomes (1)

  • Treatment Failures at 7 Days

    worsening abscess or new recurrence of abscess

    7 days

Study Arms (2)

bactrim DS (800/160) 2 pills po BID x 7 days

ACTIVE COMPARATOR

active comparator

Drug: bactrim

Matched placebo 2 pills po BID x 7 days

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

bactrimDRUG

bactrim DS (800/160) 2 pills PO BID x 7 days

bactrim DS (800/160) 2 pills po BID x 7 days
placeboDRUG

placebo 2 pills po BID x 7 days

Matched placebo 2 pills po BID x 7 days

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Additionally, any 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.
  • Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
  • Patients with fever or evidence of systemic infection
  • Finally, 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

Related Publications (1)

  • Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.

    PMID: 20346539DERIVED

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
Washington Hospital Center
gillianmd@gmail.com
919-724-9185

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

November 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 9, 2010

Results First Posted

March 2, 2010

Record last verified: 2009-09

Locations

US(1)