NCT05846399 CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 72 participants in total. It began in 2023-09-07 with a primary completion date of 2027-07-01.

Brief Summary

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

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 1. Purulent drainage from the cat bite 2. 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 * Received antibiotics within the past 30 days * Patients unwilling to take study medication * Patients unwilling to attend scheduled follow-up evaluations or complete study forms * Pregnant Women * Type I hypersensitivity reaction to any of the study interventions * Immunocompromised patients (primary and secondary immunodeficiencies) Primary * Autoimmune Lymphoproliferative Syndrome (ALPS) * Autoimmune Polyglandular Syndrome type 1 (APS-1) * B-cell Expansion with Nuclear factor kappa-light-chain-enhancer of activated B cells and T-cell Anergy (BENTA) Disease * Caspase Eight Deficiency State (CEDS) * Caspase Recruitment Domain Family Member 9 (CARD9) Deficiency and Other Syndromes of Susceptibility to Candidiasis * Cartilage-hair hypoplasia * Chédiak-Higashi syndrome * Chronic Granulomatous Disease (CGD) * Common Variable Immunodeficiency (CVID) * Complement Deficiencies * Congenital Neutropenia Syndromes * Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA4) Deficiency * Cyclic neutropenia * DiGeorge syndrome * Dedicator Of Cytokinesis 8 (DOCK8) Deficiency * GATA-binding protein 2 (GATA2) Deficiency * Glycosylation Disorders with Immunodeficiency * Hyper-Immunoglobulin E Syndromes (HIES) * Hyper-Immunoglobulin M Syndromes * Interferon Gamma, Interleukin 12 and Interleukin 23 Deficiencies * Leukocyte Adhesion Deficiency (LAD) Types 1 and 2 * Lipopolysaccharide Responsive Beige-Like Anchor Protein (LRBA) Deficiency * Phosphatidylinositol 3-kinase (PI3-Kinase) Disease * Phospholipase C gamma 2 (PLCG2) associated Antibody Deficiency and Immune Dysregulation (PLAID) * Severe Combined Immunodeficiency (SCID) * Selective Immunoglobulin A (IgA) deficiency * Signal transducer and activator of transcription 3 (STAT3) Dominant-Negative Disease * STAT3 Gain-of-Function Disease * Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome * Wiskott-Aldrich Syndrome (WAS) * X-Linked Agammaglobulinemia (XLA) * X-Linked Lymphoproliferative Disease (XLP) * X-linked magnesium transporter 1 (MAGT1) deficiency with increased susceptibility to Epstein-Barr virus (EBV) infection and N-linked glycosylation defect (XMEN) Disease * Zeta-associated protein 70 (ZAP-70) deficiency Secondary * Malnutrition * Uncontrolled Diabetes mellitus * Chronic uremia * Genetic syndromes: trisomy 21 * Immunomodulatory, immunosuppressive drug therapy: corticosteroids, calcineurin inhibitors, cytotoxic agents * Systemic lupus erythematosus * Malignancy * Active radiation therapy * Bone marrow ablation * Infectious diseases: human immunodeficiency virus (HIV) infection, Hepatitis Additional 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

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