| CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial | |
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| Approved on: | 2024-09-18 |
| Brief purpose of the study: | The overall goal of the study is to determine if oral antibiotics are appropriate and the appropriate duration for prophylactic oral antibiotics following cat bite injuries to the hand/forearm without signs of infection within the first 24 hours of the cat bite. |
| Brief summary of what participants will be asked to do: | Participants will complete a basic demographic form, QuickDASH form, and HAND-Q form at baseline. All participants will receive thorough wound management with antiseptic solutions and topical antibiotic ointments. Participants will be randomized to one of three treatment arms (placebo; amoxicillin-clavulanate 1 day; amoxicillin-clavulanate 5 days). 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 digital camera, and infrared camera. Disability and quality of life will by assessed by QuickDASH forms and HAND-Q forms at day 0, day 2, day 7 +/-2, day 14 +/-2 and day 30 +/-2. Day 0 assessments will be performed either at the emergency department, urgent care, or University Hospital Surgery Clinic. Day 2, day 7 +/-, day 14 +/-, day 30+/-2 assessments will be performed at the University Hospital Surgery Clinic. |
| Basic eligibility criteria: | Inclusion criteria -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. -English speaking Exclusion criteria -Patients who present with active local or systemic infections. -Received antibiotics within the past 30 days. -Patients unwilling to take study medication. -Pregnant women. -Type I hypersensitivity reaction to any of the study interventions. -Immunocompromised patients (primary and secondary immunodeficiencies). Primary and secondary immunodeficiencies can be found at the following link. https://www.merckmanuals.com/professional/immunology-allergic-disorders/immunodeficiency-disorders/overview-of-immunodeficiency-disorders |
| Study contact for more information: | Kevin M. Klifto, DO, PharmD; Email: kmkdg2@health.missouri.edu; (Phone: 573-884-8176) |
| IRB Number: | 2092043 MU |