Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846399
Status:
RECRUITING
Last Update Posted:
2023-09-11
First Post:
2023-04-12
Brief Title:
CAT BITE Antibiotic Prophylaxis for the HandForearm CATBITE
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
CAT BITE Antibiotic Prophylaxis and Durations for the HandForearm CATBITE a Prospective Randomized Placebo-controlled Double-blinded Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATBITE
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 handforearm 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 inclusionexclusion 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 andor 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 handforearm will be assessed for correlations with infections
Detailed Description:
Cat bites have been reported as the second most common domestic animal bite in the United States ranging from 5-15 of all bites The hand is the most common site of bite injuries Cat bites are puncture wounds that have the potential to seed bacteria deep within the joint capsule periosteum and bone As a result infection is a serious complication reported in 30-50 of cat bites The median time to signs and symptoms of infection following a cat bite is typically short approximately 12 hours Direct healthcare costs associated with management of cat and dog bites in the United States estimate 850000000 annually and do not consider the indirect costs associated with time off work rehabilitation and permanent impairment
The average cat bite wound culture yields five types of bacterial isolates Mixed aerobic and anaerobic bacteria are observed in 60 of cases Pasteurella multocida is the is the most common organism isolated from the mouths of cats that can cause infections after a bite Pasteurella species are isolated from 75 of cat bite wounds and the incubation period for Pasteurella infection is one to three days Capnocytophaga canimorsus can cause bacteremia and fatal sepsis after animal bites especially in patients with asplenia alcoholism or underlying hepatic disease The incubation period for Capnocytophaga infection is one to three days Bartonella henselae may be transmitted via the bite of an infected cat and contact with cat saliva via broken skin or mucosal surfaces The incubation period for Bartonella infection is 7 to 14 days Anaerobes isolated from dog and cat bite wounds include Bacteroides species fusobacteria Porphyromonas species Prevotella species cutibacteria formerly propionibacteria and peptostreptococci
Prophylactic antibiotics are often recommended to decrease the incidence of developing an infection Broad antibiotic coverage is recommended to address the polymicrobial nature of common oral flora and bite infections Pasteurella species are generally susceptible to penicillin and ampicillin but staphylococci and anaerobic species often produce beta-lactamase which provides resistance to these antibiotics Adding a beta-lactamase inhibitor significantly increases the effectiveness of these antibiotics and amoxicillin-clavulanate is the oral antibiotic of choice for human dog and cat bites Infectious Diseases Society of America IDSA guidelines recommend antibiotic prophylaxis with amoxicillin-clavulanate 875-125mg twice daily BID for 3-5 days or ciprofloxacin 500-750mg BID clindamycin 300-450mg three times daily TID if a participant has a penicillin allergy However only one randomized controlled clinical trial RCT has been performed to date to assess the efficacy of prophylactic antibiotics following cat bites Adult participants with uninfected full-thickness wounds presenting within 24 hours of injury to the emergency department were considered Participants were randomly assigned to receive oxacillin 500mg four times daily QID for five days n5 or identically appearing placebo n6 Four of six participants receiving placebo but none of the five participants receiving oxacillin developed a wound infection P 0045
Immunocompetent adult participants presenting within 24 hours of a cat bite without any signs or symptoms of infection may benefit from advances in wound care alone or only need a maximum of 24 hours of antibiotic prophylaxis Furthermore a Cochrane review aggregating data from clinical trials from the literature concluded There is no evidence that the use of prophylactic antibiotics is effective for cat or dog bites The investigators hypothesis is that administration of 5 days of prophylactic antibiotics will not reduce the incidence of infection in participants evaluated and treated within 24 hours of cat bite injury who do not exhibit signs of an active infection
The average cat bite wound culture yields five types of bacterial isolates Mixed aerobic and anaerobic bacteria are observed in 60 of cases Pasteurella multocida is the is the most common organism isolated from the mouths of cats that can cause infections after a bite Pasteurella species are isolated from 75 of cat bite wounds and the incubation period for Pasteurella infection is one to three days Capnocytophaga canimorsus can cause bacteremia and fatal sepsis after animal bites especially in patients with asplenia alcoholism or underlying hepatic disease The incubation period for Capnocytophaga infection is one to three days Bartonella henselae may be transmitted via the bite of an infected cat and contact with cat saliva via broken skin or mucosal surfaces The incubation period for Bartonella infection is 7 to 14 days Anaerobes isolated from dog and cat bite wounds include Bacteroides species fusobacteria Porphyromonas species Prevotella species cutibacteria formerly propionibacteria and peptostreptococci
Prophylactic antibiotics are often recommended to decrease the incidence of developing an infection Broad antibiotic coverage is recommended to address the polymicrobial nature of common oral flora and bite infections Pasteurella species are generally susceptible to penicillin and ampicillin but staphylococci and anaerobic species often produce beta-lactamase which provides resistance to these antibiotics Adding a beta-lactamase inhibitor significantly increases the effectiveness of these antibiotics and amoxicillin-clavulanate is the oral antibiotic of choice for human dog and cat bites Infectious Diseases Society of America IDSA guidelines recommend antibiotic prophylaxis with amoxicillin-clavulanate 875-125mg twice daily BID for 3-5 days or ciprofloxacin 500-750mg BID clindamycin 300-450mg three times daily TID if a participant has a penicillin allergy However only one randomized controlled clinical trial RCT has been performed to date to assess the efficacy of prophylactic antibiotics following cat bites Adult participants with uninfected full-thickness wounds presenting within 24 hours of injury to the emergency department were considered Participants were randomly assigned to receive oxacillin 500mg four times daily QID for five days n5 or identically appearing placebo n6 Four of six participants receiving placebo but none of the five participants receiving oxacillin developed a wound infection P 0045
Immunocompetent adult participants presenting within 24 hours of a cat bite without any signs or symptoms of infection may benefit from advances in wound care alone or only need a maximum of 24 hours of antibiotic prophylaxis Furthermore a Cochrane review aggregating data from clinical trials from the literature concluded There is no evidence that the use of prophylactic antibiotics is effective for cat or dog bites The investigators hypothesis is that administration of 5 days of prophylactic antibiotics will not reduce the incidence of infection in participants evaluated and treated within 24 hours of cat bite injury who do not exhibit signs of an active infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None