RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): a Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial

Quick Facts

Study Start:2023-09-07
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05846399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients greater or equal to 18 years of age.
  2. * Bitten by a cat.
  3. * Location of bite is the hand and/or forearm (distal to elbow).
  4. * Presenting \<24 hours following a cat bite to the hand/forearm.
  5. * English speaking
  1. * Patients who present with active local or systemic infections
  2. 1. Purulent drainage from the cat bite
  3. 2. Redness AND swelling at the location of the cat bite
  4. * Having a fever \>100.4° F or \>38° C)-Received antibiotics within the past 30 days
  5. * Received antibiotics within the past 30 days
  6. * Patients unwilling to take study medication
  7. * Patients unwilling to attend scheduled follow-up evaluations or complete study forms
  8. * Pregnant Women
  9. * Type I hypersensitivity reaction to any of the study interventions
  10. * Immunocompromised patients (primary and secondary immunodeficiencies) Primary
  11. * Autoimmune Lymphoproliferative Syndrome (ALPS)
  12. * Autoimmune Polyglandular Syndrome type 1 (APS-1)
  13. * B-cell Expansion with Nuclear factor kappa-light-chain-enhancer of activated B cells and T-cell Anergy (BENTA) Disease
  14. * Caspase Eight Deficiency State (CEDS)
  15. * Caspase Recruitment Domain Family Member 9 (CARD9) Deficiency and Other Syndromes of Susceptibility to Candidiasis
  16. * Cartilage-hair hypoplasia
  17. * Chédiak-Higashi syndrome
  18. * Chronic Granulomatous Disease (CGD)
  19. * Common Variable Immunodeficiency (CVID)
  20. * Complement Deficiencies
  21. * Congenital Neutropenia Syndromes
  22. * Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA4) Deficiency
  23. * Cyclic neutropenia
  24. * DiGeorge syndrome
  25. * Dedicator Of Cytokinesis 8 (DOCK8) Deficiency
  26. * GATA-binding protein 2 (GATA2) Deficiency
  27. * Glycosylation Disorders with Immunodeficiency
  28. * Hyper-Immunoglobulin E Syndromes (HIES)
  29. * Hyper-Immunoglobulin M Syndromes
  30. * Interferon Gamma, Interleukin 12 and Interleukin 23 Deficiencies
  31. * Leukocyte Adhesion Deficiency (LAD) Types 1 and 2
  32. * Lipopolysaccharide Responsive Beige-Like Anchor Protein (LRBA) Deficiency
  33. * Phosphatidylinositol 3-kinase (PI3-Kinase) Disease
  34. * Phospholipase C gamma 2 (PLCG2) associated Antibody Deficiency and Immune Dysregulation (PLAID)
  35. * Severe Combined Immunodeficiency (SCID)
  36. * Selective Immunoglobulin A (IgA) deficiency
  37. * Signal transducer and activator of transcription 3 (STAT3) Dominant-Negative Disease
  38. * STAT3 Gain-of-Function Disease
  39. * Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome
  40. * Wiskott-Aldrich Syndrome (WAS)
  41. * X-Linked Agammaglobulinemia (XLA)
  42. * X-Linked Lymphoproliferative Disease (XLP)
  43. * X-linked magnesium transporter 1 (MAGT1) deficiency with increased susceptibility to Epstein-Barr virus (EBV) infection and N-linked glycosylation defect (XMEN) Disease
  44. * Zeta-associated protein 70 (ZAP-70) deficiency
  45. * Malnutrition
  46. * Uncontrolled Diabetes mellitus
  47. * Chronic uremia
  48. * Genetic syndromes: trisomy 21
  49. * Immunomodulatory, immunosuppressive drug therapy: corticosteroids, calcineurin inhibitors, cytotoxic agents
  50. * Systemic lupus erythematosus
  51. * Malignancy
  52. * Active radiation therapy
  53. * Bone marrow ablation
  54. * Infectious diseases: human immunodeficiency virus (HIV) infection, Hepatitis

Contacts and Locations

Study Contact

Stephen H Colbert, MD
CONTACT
573-882-2277
ColbertS@health.missouri.edu
Kevin M Klifto, DO, PharmD
CONTACT
573-882-2277
kmkdg2@health.missouri.edu

Principal Investigator

Kevin M Klifto, DO, PharmD
PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia

Study Locations (Sites)

University of Missouri
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

  • Kevin M Klifto, DO, PharmD, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-07
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2023-09-07
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cat Bite
  • Hand Injuries
  • Arm Injury
  • Infection, Bacterial
  • Anti-bacterial Agents