BitePhase 2/3NCT00185939
The Use of Prophylactic Antibiotics In the Management of Dog Bites
A Phase 2/3 study testing Augmentin in people with Bite and Wound, run by Stanford University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Augmentin
- How many people
- 125 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2003to Nov 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mills Peninsula Hospital
Burlingame, California
UCSF Medical Center
San Francisco, California, 94143
Stanford University Medical Center
Stanford, California, 94305
About this study
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.
Read the detailed description
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.
- Being tested
- Augmentin
- Keywords
- dog bites, infection, prophylactic antibiotics, cost effectiveness
- Medical subject headings
- Bites and Stings, Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AugmentinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection
Secondary outcomes (1)
side effects of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiteStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- James V Quinn, MD MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185939
- Sponsor's protocol ID
- K23AR002137
- Status last verified
- Dec 2006
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Prophylactic Antibiotics In the Management of Dog Bites
- ClinicalTrials.gov ID
- NCT00185939
- Acronym / sponsor ID
- K23AR002137
- Keywords
- dog bites, infection, prophylactic antibiotics, cost effectiveness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2003
- Study completion
- Nov 2005
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmentin | Drug | – |
Primary outcome
Wound infection
1 secondary outcome
side effects of medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James V Quinn, MD MS principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Augmentin in people with Bite and Wound, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2006.