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

NCT05846399 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2092043
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores

  Day 30+/-2

• Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores

  Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2

• HAND Questionnaire (HAND-Q) scores

  Day 30+/-2

• Changes in HAND Questionnaire (HAND-Q) scores

  Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2

• Adverse effects

  Day 30+/-2

Other Outcomes (2)

• Location of cat bites that result in infection

  Day 30+/-2

• Changes in location of cat bites that result in infection

  Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2

Study Arms (3)

Placebo (microcrystalline cellulose)

PLACEBO COMPARATOR

Placebo capsules by mouth twice daily x 5 days (5 days of placebo microcrystalline cellulose capsules)

Other: Placebo (microcrystalline cellulose); Procedure: Wound management

Antibiotic x 1 day

ACTIVE COMPARATOR

Amoxicillin-clavulanate 875-125mg capsules by mouth twice daily x 1 day (4 days of placebo capsules) -Penicillin allergy: ciprofloxacin 500mg by mouth twice daily + clindamycin 300mg by mouth three times daily x 1 day

Drug: Amoxicillin/clavulanate; Drug: Ciprofloxacin; Drug: Clindamycin; Other: Placebo (microcrystalline cellulose); Procedure: Wound management

Antibiotic x 5 days

ACTIVE COMPARATOR

Amoxicillin-clavulanate 875-125mg capsules by mouth twice daily x 5 days (0 days of placebo capsules) -Penicillin allergy: ciprofloxacin 500mg by mouth twice daily + clindamycin 300mg by mouth three times daily x 5 days

Drug: Amoxicillin/clavulanate; Drug: Ciprofloxacin; Drug: Clindamycin; Procedure: Wound management

Interventions

Amoxicillin/clavulanate DRUG

Amoxicillin-clavulanate 875-125mg by mouth twice daily for 1 day or Ciprofloxacin 500mg by mouth twice daily and clindamycin 450mg by mouth twice daily for 1 day

Also known as: Augmentin; Clavulin; Betacillin; Clavamox

Antibiotic x 1 day; Antibiotic x 5 days

Ciprofloxacin DRUG

Amoxicillin-clavulanate 875-125mg by mouth twice daily for 5 days or Ciprofloxacin 500mg by mouth twice daily and clindamycin 450mg by mouth twice daily for 5 days

Also known as: Cipro

Antibiotic x 1 day; Antibiotic x 5 days

Clindamycin DRUG

Amoxicillin-clavulanate 875-125mg by mouth twice daily for 5 days or Ciprofloxacin 500mg by mouth twice daily and clindamycin 450mg by mouth twice daily for 5 days

Also known as: Cleocin

Antibiotic x 1 day; Antibiotic x 5 days

Placebo (microcrystalline cellulose) OTHER

Placebo (microcrystalline cellulose) by mouth twice daily by mouth for 5 days

Also known as: (C6H10O5)n

Antibiotic x 1 day; Placebo (microcrystalline cellulose)

Wound management PROCEDURE

Wound management includes hemostasis, copious irrigation, removal of foreign bodies, and excisional debridement of devitalized tissue. If only punctures are present, lancing of the punctures is not typically required unless infection has already developed. Local anesthesia (1% lidocaine hydrogen chloride (HCl) with epinephrine 1:100,000; 200mg/20mL vial) will be used prior to irrigation (30mL of povidone-iodine in 1L of 0.9% sodium chloride (NaCl) solution and/or 118mL of 3% hydrogen peroxide) and debridement. Open wounds will be irrigated and debrided at bedside. Wounds will be covered with soft dressings in place until first follow-up at day 2.

Antibiotic x 1 day; Antibiotic x 5 days; Placebo (microcrystalline cellulose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who present with active local or systemic infections
• Purulent drainage from the cat bite
• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (13)

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  PMID: 8773720 BACKGROUND

• Sierakowski K, Dean NR, Pusic AL, Cano SJ, Griffin PA, Bain GI, Klassen A, Lalonde D. International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q). BMJ Open. 2019 Mar 20;9(3):e025822. doi: 10.1136/bmjopen-2018-025822.

  PMID: 30898824 BACKGROUND

• Bregman B, Slavinski S. Using emergency department data to conduct dog and animal bite surveillance in New York City, 2003-2006. Public Health Rep. 2012 Mar-Apr;127(2):195-201. doi: 10.1177/003335491212700208.

  PMID: 22379219 BACKGROUND

• Kwo S, Agarwal JP, Meletiou S. Current treatment of cat bites to the hand and wrist. J Hand Surg Am. 2011 Jan;36(1):152-3. doi: 10.1016/j.jhsa.2009.10.008. Epub 2009 Dec 14. No abstract available.

  PMID: 20006917 BACKGROUND

• Benson LS, Edwards SL, Schiff AP, Williams CS, Visotsky JL. Dog and cat bites to the hand: treatment and cost assessment. J Hand Surg Am. 2006 Mar;31(3):468-73. doi: 10.1016/j.jhsa.2005.12.011.

  PMID: 16516744 BACKGROUND

• Kennedy SA, Stoll LE, Lauder AS. Human and other mammalian bite injuries of the hand: evaluation and management. J Am Acad Orthop Surg. 2015 Jan;23(1):47-57. doi: 10.5435/JAAOS-23-01-47.

  PMID: 25538130 BACKGROUND

• Talan DA, Citron DM, Abrahamian FM, Moran GJ, Goldstein EJ. Bacteriologic analysis of infected dog and cat bites. Emergency Medicine Animal Bite Infection Study Group. N Engl J Med. 1999 Jan 14;340(2):85-92. doi: 10.1056/NEJM199901143400202.

  PMID: 9887159 BACKGROUND

• Medeiros I, Saconato H. Antibiotic prophylaxis for mammalian bites. Cochrane Database Syst Rev. 2001;(2):CD001738. doi: 10.1002/14651858.CD001738.

  PMID: 11406003 BACKGROUND

• Lloret A, Egberink H, Addie D, Belak S, Boucraut-Baralon C, Frymus T, Gruffydd-Jones T, Hartmann K, Hosie MJ, Lutz H, Marsilio F, Mostl K, Pennisi MG, Radford AD, Thiry E, Truyen U, Horzinek MC. Pasteurella multocida infection in cats: ABCD guidelines on prevention and management. J Feline Med Surg. 2013 Jul;15(7):570-2. doi: 10.1177/1098612X13489215.

  PMID: 23813817 BACKGROUND

• Stevens DL, Bisno AL, Chambers HF, Everett ED, Dellinger P, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan EL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. doi: 10.1086/497143. Epub 2005 Oct 14. No abstract available.

  PMID: 16231249 BACKGROUND

• Coburn B, Toye B, Rawte P, Jamieson FB, Farrell DJ, Patel SN. Antimicrobial susceptibilities of clinical isolates of HACEK organisms. Antimicrob Agents Chemother. 2013 Apr;57(4):1989-91. doi: 10.1128/AAC.00111-13. Epub 2013 Feb 12.

  PMID: 23403420 BACKGROUND

• Beasley H, Borgmann AR, McDonald TO, Belluscio PR. Carbachol in cataract surgery. Arch Ophthalmol. 1968 Jul;80(1):39-41. doi: 10.1001/archopht.1968.00980050041006. No abstract available.

  PMID: 5660015 BACKGROUND

• Elenbaas RM, McNabney WK, Robinson WA. Evaluation of prophylactic oxacillin in cat bite wounds. Ann Emerg Med. 1984 Mar;13(3):155-7. doi: 10.1016/s0196-0644(84)80604-6.

  PMID: 6696302 BACKGROUND

MeSH Terms

Conditions

Hand Injuries; Arm Injuries; Bacterial Infections

Interventions

Amoxicillin-Potassium Clavulanate Combination; Ciprofloxacin; Clindamycin; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Kevin M Klifto, DO, PharmD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A double-blinded protocol will be performed. Investigators and participants will be blinded to study interventions. Both will be blinded to reduce the risk of bias. All three interventions will be packaged in identical capsule vials. The placebo arm will have all capsules filled with microcrystalline cellulose and no active drug, the one day intervention arm will be packaged in identical capsule vials with the first day of active drug and four days filled with placebo, five day intervention group will be packaged in identical capsule vials with all capsules filled with active drug. Blinding will remain throughout the duration of the study. Following completion of patient participation (day 30+/-2). Investigators and participants will be notified of the respective treatment arms. Final results will be available to investigators and participants following completion of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CHIEF OF DIVISION OF PLASTIC SURGERY AND PROFESSOR OF SURGERY

Model Details: Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)