CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia
About this trial
Cat bites are puncture wounds that have the potential to seed bacteria deep within the joint capsule, periosteum, and bone. The hand is the most common site of bite injuries. Pasteurella multocida is the is the most common organism isolated from the mouths of cats that can cause infections after a bite. Prophylactic antibiotics are often recommended with amoxicillin-clavulanate for 3-5 days to decrease the incidence of developing an infection. However, only one randomized controlled clinical trial consisting of 12 patients has been performed to justify this course of treatment, raising the possibility that the use of antibiotics could be reduced or even eliminated. Investigators will compare different durations of prophylactic antibiotics and a placebo control for cat bites to the hand/forearm presenting to the Emergency Department, Urgent Care, Plastic Surgery Clinic using a randomized, controlled, double-blind clinical trial. Participants presenting to the University of Missouri Hospital Emergency Department, Missouri University (MU) Healthcare Urgent Care, Plastic Surgery Clinic over the next year will be offered the chance to enroll if they meet the inclusion/exclusion criteria. For inclusion, participants will be \>18 years of age, have cat bites to the hand or distal to elbow, and present within 24 hours of the cat bite injury. Participants must not present with active local or systemic infections, have received antibiotics within the past 30 days, or be immunocompromised (primary and secondary immunodeficiencies). Participants will be randomized to one of three treatment arms (placebo; amoxicillin-clavulanate 1 day; amoxicillin-clavulanate 5 days). Outcomes are the development of an infection at the location of the cat bite and/or systemic infection, adverse effects of interventions, disability assessed by Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores, and quality of life (QOL) assessed by HAND Questionnaire (HAND-Q) scores. Infection will be assessed at day 0, day 2, day 7+/-2, day 14+/-2, and day 30+/-2 by vital signs, laboratory values, physical examination and with an infrared and digital camera. All measures will be within the standard of care, apart from the infrared camera, QuickDASH, and HAND-Q scores. The anatomic locations of cat bites to the hand/forearm will be assessed for correlations with infections.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients greater or equal to 18 years of age.
Bitten by a cat.
Location of bite is the hand and/or forearm (distal to elbow).
Presenting <24 hours following a cat bite to the hand/forearm.
Disqualifiers
Patients who present with active local or systemic infections
Purulent drainage from the cat bite
Redness AND swelling at the location of the cat bite
Having a fever >100.4° F or >38° C)-Received antibiotics within the past 30 days
Trial design
Design model
Parallel
Treatments tested in this trial
Amoxicillin/clavulanate
DrugAmoxicillin-clavulanate 875-125mg by mouth twice daily for 1 day or Ciprofloxacin 500mg by mouth twice daily and clindamycin 450mg by mouth twice daily for 1 day
Ciprofloxacin
DrugAmoxicillin-clavulanate 875-125mg by mouth twice daily for 5 days or Ciprofloxacin 500mg by mouth twice daily and clindamycin 450mg by mouth twice daily for 5 days
Clindamycin
DrugAmoxicillin-clavulanate 875-125mg by mouth twice daily for 5 days or Ciprofloxacin 500mg by mouth twice daily and clindamycin 450mg by mouth twice daily for 5 days
Placebo (microcrystalline cellulose)
Other interventionPlacebo (microcrystalline cellulose) by mouth twice daily by mouth for 5 days
Wound management
Procedure/SurgeryWound management includes hemostasis, copious irrigation, removal of foreign bodies, and excisional debridement of devitalized tissue. If only punctures are present, lancing of the punctures is not typically required unless infection has already developed. Local anesthesia (1% lidocaine hydrogen chloride (HCl) with epinephrine 1:100,000; 200mg/20mL vial) will be used prior to irrigation (30mL of povidone-iodine in 1L of 0.9% sodium chloride (NaCl) solution and/or 118mL of 3% hydrogen peroxide) and debridement. Open wounds will be irrigated and debrided at bedside. Wounds will be covered with soft dressings in place until first follow-up at day 2.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Placebo (microcrystalline cellulose)Placebo comparator 2 interventions
Group B: Antibiotic x 1 dayActive comparator 5 interventions
Group C: Antibiotic x 5 daysActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Incidence of infection
To compare the incidence of infection (skin, soft tissue, joint, bone) between each study arm to determine the effect of antibiotic prophylaxis and duration on cat bites to the hand and/or forearm within 30 days. Infections are defined by, The Centers for Disease Control and Prevention National Healthcare Safety Network.
Time frame
Day 30+/-22
Changes of the incidence of infection
To compare changes of the incidence of infection (skin, soft tissue, joint, bone) between each study arm and within each study arm to determine the effect of antibiotic prophylaxis and duration on cat bites to the hand and/or forearm at different time points. Infections are defined by the The Centers for Disease Control and Prevention National Healthcare Safety Network.
Time frame
Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2Secondary outcomes
1
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
To compare QuickDASH scores between each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's disability following cat bites to the hand and/or forearm within 30 days. different time points. QuickDASH scores are measured on a scale of 0 to 100 (higher scores indicate increased patient-reported disability).
Time frame
Day 30+/-22
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
To compare changes in QuickDASH scores between each study arm and within each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's disability following cat bites to the hand and/or forearm at different time points. QuickDASH scores are measured on a scale of 0 to 100 (higher scores indicate increased patient-reported disability).
Time frame
Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-23
HAND Questionnaire (HAND-Q) scores
To compare HAND-Q scores between each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's quality of life following cat bites to the hand and/or forearm within 30 days. The HAND-Q is composed of independently functioning scales scored separately. To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. Items are summed to produce a total scale raw score. A conversion table is used to convert raw scores into a score that ranges from 0 (worst) to 100 (best). The conversion, which linearizes the scores, is based on the findings from the Rasch analysis. Higher scores for HAND-Q scales reflect a better outcome.
Time frame
Day 30+/-24
Changes in HAND Questionnaire (HAND-Q) scores
To compare changes in HAND-Q scores between each study arm and within each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's quality of life following cat bites to the hand and/or forearm at different time points. The HAND-Q is composed of independently functioning scales scored separately. To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. Items are summed to produce a total scale raw score. A conversion table is used to convert raw scores into a score that ranges from 0 (worst) to 100 (best). The conversion, which linearizes the scores, is based on the findings from the Rasch analysis. Higher scores for HAND-Q scales reflect a better outcome.
Time frame
Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2Other outcomes
1
Location of cat bites that result in infection
To determine if the anatomic location of the cat bite results in the development of the infection within 30 days.
Time frame
Day 30+/-22
Changes in location of cat bites that result in infection
To determine if the anatomic location of the cat bite between each study arm and within each study arm results in the development of the infection at different time points.
Time frame
Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2Sponsors and contacts
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Source ClinicalTrials.gov