Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID05846399

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

Led by University of Missouri-Columbia · Updated on 2025-10-15

72

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying cat bites to the hand and forearm to understand the best way to prevent infections after such injuries. Cat bites can introduce bacteria deep into tissues, leading to serious infections. The study evaluates whether different durations of antibiotic treatment or no antibiotics at all affect infection rates. This is a randomized, controlled, double-blind clinical trial involving adult patients presenting within 24 hours of a cat bite without signs of active infection or recent antibiotic use. Participants in this trial will be randomly assigned to one of three groups: a placebo group receiving capsules twice daily for five days; a group receiving amoxicillin-clavulanate or, for those allergic to penicillin, ciprofloxacin plus clindamycin, for one day with placebo for the remaining days; and a group receiving the same antibiotics for five days. Alongside medication, standard wound care including cleaning, removal of foreign bodies, and dressing will be provided. The study uses infrared and digital cameras to monitor wounds. During the study, infection signs will be checked at multiple points: day 0, day 2, day 7 (plus or minus 2 days), day 14 (plus or minus 2 days), and day 30 (plus or minus 2 days). Researchers will assess infection rates, side effects, disability using Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores, and quality of life using the HAND Questionnaire (HAND-Q). Participants will undergo physical exams, vital sign measurements, laboratory tests, and imaging as part of routine care and study assessments. The study will correlate bite locations with infection outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Bitten by a cat
  • Bite location on the hand and/or forearm (below the elbow)
  • Presenting within 24 hours of the cat bite
  • English speaking
Not Eligible

You will not qualify if you...

  • Active local or systemic infection signs such as pus or redness and swelling at the bite site
  • Fever higher than 100.4°F (38°C)
  • Antibiotic use within the past 30 days
  • Unwillingness to take study medication or attend follow-up visits
  • Pregnancy
  • Allergy to study medications
  • Immunocompromised conditions including primary and secondary immunodeficiencies such as Autoimmune Lymphoproliferative Syndrome, Chronic Granulomatous Disease, Severe Combined Immunodeficiency, and others
  • Malnutrition, uncontrolled diabetes, chronic uremia, trisomy 21
  • Use of immunosuppressive drugs
  • Systemic lupus erythematosus
  • Malignancy or active radiation therapy
  • Bone marrow ablation
  • Infectious diseases like HIV or Hepatitis
  • Other specific immunodeficiency disorders listed in the study details

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 24 hours before treatment

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 to 5 days

Participants receive either antibiotic prophylaxis or placebo by mouth for 1 to 5 days and undergo wound management including irrigation and debridement as needed.

1 baseline visit and 1 follow-up visit on Day 2

Follow-up

Duration - Up to 30 days

Participants are monitored for signs of infection, disability, and adverse effects after treatment ends.

Visits on Day 7, Day 14, and Day 30

Trial Site Locations

Total: 1 location

1

University of Missouri

Columbia, Missouri, United States, 65212

Actively Recruiting

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Research Team

S

Stephen H Colbert, MD

K

Kevin M Klifto, DO, PharmD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG).

P L Hudak, P C Amadio, C Bombardier

https://pubmed.ncbi.nlm.nih.gov/8773720

International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q).

Kyra Sierakowski, Nicola R Dean, Andrea L Pusic...

https://pubmed.ncbi.nlm.nih.gov/30898824