| Approved on: | 2023-09-15 |
| Brief purpose of the study: | The overall goal of the study is to determine if antibiotics are appropriate and the appropriate duration for prophylactic 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 standard wound management. 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/or 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 or urgent care. Day 2 and day 30+/-2 assessments will be performed at the University Hospital Surgery Clinic. MO code added. Sample size updated. |
| 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 |
