NCT00691600

Brief Summary

The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 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

December 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
10.2 years until next milestone

Results Posted

Study results publicly available

June 23, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

December 28, 2007

Results QC Date

August 21, 2017

Last Update Submit

June 22, 2020

Conditions

Abscess

Keywords

abscessAbscesses in the pediatric emergency population

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Abscess Resolution

    Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center

    10 days

Secondary Outcomes (2)

  • Number of Participants Requiring Admission for Failure of Abscess Resolution

    10 days

  • Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve

    10 days

Study Arms (2)

oral trimethoprim/sulfamethoxazole

ACTIVE COMPARATOR

subjects with abscesses less than 5cm will be randomized to either study med or placebo

Drug: oral trimethoprim/sulfamethoxazole

placebo

PLACEBO COMPARATOR

Placebo after incision and drainage of abscess less than 5 cm.

Drug: Placebo

Interventions

oral trimethoprim/sulfamethoxazoleDRUG

80 mg caps or 8 mg/ml suspension every 12 hours for 10 days

Also known as: TMP/SMX
oral trimethoprim/sulfamethoxazole
PlaceboDRUG

Placebo caps or suspension every 12 hours for 10 days

Also known as: Placebo caps
placebo

Eligibility Criteria

Age90 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ) Abscess \< 5 cm (\< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age \> 90 days and \< 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

You may not qualify if:

  • Multiple abscesses
  • Abscess located on the hands, face, or perineum
  • Abscess as a result of a bite wound
  • Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (\> 10 days), etc.
  • Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX
  • ) Fever \> or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.
  • ) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Abscess

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Andrea T. Cruz, MD, MPH
Organization
Baylor College of Medicine
acruz@bcm.edu
832-824-5582

Study Officials

  • Andrea Cruz, MD, MPH

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

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
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2007

First Posted

June 5, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 1, 2020

Results First Posted

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)