The Use of Prophylactic Antibiotics In the Management of Dog Bites

NCT00185939 | Completed Phase 2

• 1 other identifier: K23AR002137
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 3

Brief Summary

This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection. By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.

Conditions

Bite; Wound; Infection

Keywords

dog bites; infection; prophylactic antibiotics; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Wound infection

Secondary Outcomes (1)

• side effects of medication

Interventions

Augmentin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients including all children and English speaking/reading persons who present with a full thickness dog bite to participating emergency departments will be considered. Non-English speaking/reading subjects for whom we can provide translation for will also be considered.

You may not qualify if:

• allergy to penicillin or amoxicillin/clavulanic acid
• wounds presenting with an active infection (require antibiotics) or greater than 12 hours old.
• patients with underlying fracture, joint or neurovascular injury, or multiple trauma requiring specialty referral. Specifically any broken skin over a joint will need treatment and be excluded from the study and randomization.
• patients on immunosuppressive agents, prolonged chronic steroid use (defined as continuous use for \> 14 days, 3 times a year) active HIV disease (determined by treating physician on history) or splenectomized. (could skew one group and at risk for overwhelming sepsis and death if infected)
• patients unwilling or unable to complete the required follow-up, and those unable to provide a contact phone number

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

Mills Peninsula Hospital

Burlingame, California, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bites and Stings; Wounds and Injuries; Infections

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• James V Quinn, MD MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2003
• Study Completion: November 1, 2005
• Last Updated: December 5, 2006

Record last verified: 2006-12

Locations

US (3)