Prophylactic antibiotics for cat bites on the hand and forearm
CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial
This study is testing different lengths of antibiotic treatment for people with cat bites on their hands or forearms to see which works best to prevent infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT05846399 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of different durations of prophylactic antibiotics and a placebo for patients who have sustained cat bites to the hand or forearm. Participants will be randomly assigned to receive either amoxicillin-clavulanate, ciprofloxacin, clindamycin, or a placebo, with the aim of determining the optimal duration of antibiotic treatment to prevent infection. The study will be conducted in the Emergency Department, Urgent Care, and Plastic Surgery Clinic at the University of Missouri, focusing on patients who present within 24 hours of their injury. The trial aims to provide evidence that could potentially reduce unnecessary antibiotic use in this common injury.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been bitten by a cat on the hand or forearm and present within 24 hours of the injury.
Not a fit: Patients with active infections, those who have received antibiotics in the past 30 days, or individuals who are immunocompromised will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and targeted antibiotic use for cat bite injuries, reducing the risk of infection and antibiotic resistance.
How similar studies have performed: While there has been limited research on this specific approach, the study aims to build on previous findings that suggest a need for reevaluation of antibiotic prophylaxis in cat bite injuries.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri
- University of Missouri — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Kevin M Klifto, DO, PharmD — University of Missouri-Columbia
- Study coordinator: Stephen H Colbert, MD
- Email: ColbertS@health.missouri.edu
- Phone: 573-882-2277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.