Infection, Bacterial Clinical Trial
— CATBITEOfficial title:
CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical 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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | September 1, 2026 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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-di sorders/overview-of-immunodeficiency-disorders |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Day 30+/-2 | |
Other | 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. | Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2 | |
Primary | 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. | Day 30+/-2 | |
Primary | 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. | Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2 | |
Secondary | 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). | Day 30+/-2 | |
Secondary | 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). | Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2 | |
Secondary | 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. | Day 30+/-2 | |
Secondary | 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. | Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2 | |
Secondary | Adverse effects | To compare adverse effects between each study arm to determine the adverse effects of antibiotic prophylaxis and duration on cat bites to the hand and/or forearm within 30 days. | Day 30+/-2 | |
Secondary | Changes in adverse effects | To compare changes in adverse effects between each study arm and within each study arm to determine the adverse effects of antibiotic prophylaxis and duration on cat bites to the hand and/or forearm at different time points. | Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2 |
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