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NCT05846399 · ClinicalTrials.gov registry record · Phase 4
CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)
A Phase 4 study of Hand Injuries and Arm Injury, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05846399 is a Phase 4 study of Hand Injuries and Arm Injury that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 72 participants, above the 28-participant average among 5 other Hand Injuries trials with a reported enrollment target (157% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05846399, a Phase 4 study of Hand Injuries and Arm Injury, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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 b
Conditions Studied
Interventions
- DRUG Ciprofloxacin
- DRUG Clindamycin
- DRUG Amoxicillin/clavulanate
- OTHER Placebo (microcrystalline cellulose)
- PROCEDURE Wound management
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-09-07 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05846399
The ClinicalTrials.gov registry entry for NCT05846399 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 28-participant average among 5 other Hand Injuries trials with a reported enrollment target (157% higher). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Hand Injuries appearing as the primary indexed condition, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT05846399 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05846399 about?
NCT05846399 is a clinical study titled "CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)". 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 b...
What is the current status of trial NCT05846399?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2023-09-07. Estimated completion is 2027-08-01.
What conditions does trial NCT05846399 study?
This clinical trial studies the following conditions: Hand Injuries, Arm Injury, Infection, Bacterial, Anti-bacterial Agents, Cat Bite.
What interventions are being tested in trial NCT05846399?
The interventions under investigation include: Ciprofloxacin (DRUG), Clindamycin (DRUG), Amoxicillin/clavulanate (DRUG), Placebo (microcrystalline cellulose) (OTHER), Wound management (PROCEDURE).
Who is sponsoring clinical trial NCT05846399?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05846399 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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