Antibiotics for Cat Bite Injuries

(CATBITE Trial)

Overseen By Kevin M Klifto, DO, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Must not be taking: Corticosteroids, Calcineurin inhibitors

Disqualifiers: Immunocompromised, Diabetes, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 38

Duration: 1-5 days

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether antibiotics taken after a cat bite to the hand or forearm can prevent infection. Researchers compare three approaches: no antibiotics, one-day antibiotics, and five-day antibiotics. The goal is to determine if shorter or no antibiotic treatments are as effective as longer ones. Individuals bitten by a cat on the hand or forearm who haven't taken antibiotics in the last 30 days might qualify for this study. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand its benefits for more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have taken antibiotics in the past 30 days or are on immunosuppressive drugs, you may not be eligible to participate.

What is the safety track record for these treatments?

Research shows that amoxicillin-clavulanate is often recommended for cat bites to prevent infections. Cat bites can cause deep wounds, which are likely to get infected. Amoxicillin-clavulanate effectively reduces this risk. However, some studies found that people taking amoxicillin-clavulanate experienced slightly more side effects than those taking only amoxicillin. These side effects were not severe and included stomach upset.

For those allergic to penicillin, a combination of ciprofloxacin and clindamycin serves as an alternative. In the past, clindamycin was ineffective against certain bacteria, like Pasteurella multocida, which is common in cat bites. Despite this, the combination remains in use when necessary due to allergies.

In this trial, the treatment has reached a phase that usually indicates it is considered safe for many people. The focus is on finding the best duration for taking these antibiotics, suggesting that most safety concerns are already well understood. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for cat bite injuries, which often involve extended courses of antibiotics, the trial explores the potential of a shorter regimen. Researchers are particularly interested in whether a one-day course of amoxicillin-clavulanate, which combines an antibiotic with a beta-lactamase inhibitor, can be just as effective as the traditional five-day course. This could mean quicker recovery times and reduced antibiotic exposure, which is crucial in preventing antibiotic resistance. For those with penicillin allergies, the trial also tests a combination of ciprofloxacin and clindamycin, offering alternative options without compromising effectiveness. This approach is promising because it may simplify treatment protocols while maintaining or even improving outcomes.

What evidence suggests that this trial's treatments could be effective for cat bite injuries?

Research shows that amoxicillin-clavulanate is the preferred antibiotic to prevent infections from animal bites, such as cat bites. It stops bacteria from spreading in the body. In this trial, participants will join different treatment arms to evaluate the effectiveness of amoxicillin-clavulanate. One arm will receive the antibiotic for 1 day, another for 5 days, and a placebo arm will serve as a comparison. Previous studies found no major difference in infection rates when using this antibiotic for prevention. Another source suggested that taking amoxicillin-clavulanate for 3-5 days can reduce the risk of infection after a cat bite. This antibiotic is often recommended to prevent infections from bites on the hands or forearms. Overall, evidence supports using amoxicillin-clavulanate to lower the risk of infection after a cat bite. ^{1 3 4 6 7}

Who Is on the Research Team?

Kevin M Klifto, DO, PharmD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

Adults over 18 who've been bitten by a cat on the hand or forearm within the last 24 hours can join this trial. They must speak English and be willing to take medication and attend follow-ups. Excluded are those with active infections, recent antibiotic use, immunodeficiencies, certain chronic diseases, fever above 100.4°F, pregnancy, malnutrition or hypersensitivity to study drugs.

Inclusion Criteria

English speaking

Bitten by a cat

I was bitten by a cat on my hand or forearm less than 24 hours ago.

Exclusion Criteria

I currently have an active infection.

I have redness and swelling where a cat bit me.

I currently have a fever higher than 100.4° F.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either placebo or amoxicillin-clavulanate for 1 or 5 days

1-5 days

Day 0, Day 2

Follow-up

Participants are monitored for infection development and adverse effects

4 weeks

Day 7, Day 14, Day 30

Outcome Assessment

Assessment of QuickDASH and HAND-Q scores to evaluate disability and quality of life

4 weeks

Day 30

What Are the Treatments Tested in This Trial?

Interventions

• Amoxicillin/clavulanate
• Placebo (microcrystalline cellulose)

Trial Overview

The CATBITE trial is testing if antibiotics prevent infection after a cat bite to the hand/forearm. Participants will randomly receive either a placebo; amoxicillin-clavulanate for one day; or amoxicillin-clavulanate for five days. The study will monitor infection development and assess disability and quality of life through questionnaires.

How Is the Trial Designed?

Group I: Antibiotic x 1 day Active Control 5 Interventions

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

Group II: Antibiotic x 5 days Active Control 4 Interventions

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

Group III: Placebo (microcrystalline cellulose) Placebo Group 2 Interventions

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

Amoxicillin/clavulanate is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Augmentin for:

• Bacterial infections
• Respiratory tract infections
• Skin and soft tissue infections
• Urinary tract infections

Approved in United States as Augmentin for:

• Lower respiratory tract infections
• Otitis media
• Sinusitis
• Skin and skin structure infections
• Urinary tract infections

Approved in Canada as Clavamox for:

• Bacterial infections
• Respiratory tract infections
• Skin and soft tissue infections
• Urinary tract infections

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

In a study of 185 patients with full thickness animal bite wounds, prophylactic antibiotics (amoxycillin/clavulanate) showed no significant benefit for wounds less than 9 hours old.

For wounds aged 9-24 hours, the use of antibiotics significantly reduced the infection rate, suggesting they are beneficial in this time frame, while their use in newer injuries is questioned unless deeper structures like tendons or joints are involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative double blind study of amoxycillin/clavulanate vs placebo in the prevention of infection after animal bites. Brakenbury, PH., Muwanga, C.[2019]

In the Netherlands, animal bites lead to significant infections, particularly from Pasteurella multocida, which can cause serious complications, as seen in three reported cases of wound healing disturbances.

For cat bites, a 5-day course of amoxicillin/clavulanic acid (Augmentin) is recommended as prophylaxis due to the high infection risk, while the necessity of prophylaxis for dog bites is debated, especially considering potential severe infections from Capnocytophaga canimorsus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pasteurella multocida infections: bites by dogs or cats?]. Tjong Joe Wai, R., van Zeijl, JH.[2006]

Infections are the most common complication from animal bites in children, and the choice of antibiotic therapy should be tailored based on individual risk factors such as the type and location of the bite, and the patient's health status.

For most bacterial infections resulting from bites, the combination of amoxicillin and clavulanic acid is the most effective treatment, and it should be started quickly and continued for 3-5 days while monitoring for local symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antibiotic prophylaxis for bites in children]. Quinet, B., Grimprel, E.[2013]

In a study involving healthy cats, both intravenous and oral doses of amoxicillin (AMX) and clavulanic acid (CLV) showed rapid absorption and elimination, with AMX having a bioavailability of 75.57% and CLV at 98.15%.

The combination of AMX and CLV at a dosage of 12.5 mg/kg is predicted to effectively treat bacterial infections in cats, maintaining drug levels above the minimum inhibitory concentration for at least 12 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of the amoxicillin-clavulanic acid combination after intravenous and oral administration in cats. Yang, F., Yang, F., Wang, G., et al.[2020]

Exotic pet-related injuries, such as those from parrot bites, require special attention due to the unique pathogens they can transmit, which are not adequately covered by standard antibiotics like amoxicillin/clavulanic acid.

A case report highlights the need for thorough microbiological assessment in managing injuries from exotic pets, emphasizing that typical treatment protocols may not be sufficient for these types of wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing parrot bite injuries to the hand: not just another animal bite. King, IC., Freeman, H., Wokes, JE.[2018]

In a study involving 61 patients with bite wounds, both penicillin (with or without dicloxacillin) and amoxicillin/clavulanic acid were found to be equally effective in treating infections, achieving a high cure rate of 87-96%.

However, patients receiving amoxicillin/clavulanic acid experienced more frequent side effects, such as loose stools or diarrhea, compared to those treated with penicillin or dicloxacillin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient therapy of bite wounds. Demographic data, bacteriology, and a prospective, randomized trial of amoxicillin/clavulanic acid versus penicillin +/- dicloxacillin. Goldstein, EJ., Reinhardt, JF., Murray, PM., et al.[2019]

Clavulanate-potentiated amoxycillin significantly improved the resolution of skin lesions in dogs compared to amoxycillin alone, with faster healing observed in experimental infections (P < 0.05).

In clinical cases, dogs and cats treated with clavulanate-potentiated amoxycillin required a shorter treatment duration and had a higher success rate, particularly against amoxycillin-resistant infections (P < 0.01).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of clavulanate-potentiated amoxycillin in experimental and clinical skin infections. Bywater, RJ., Hewett, GR., Marshall, AB., et al.[2019]

Dog bites, especially in children, are common and often lead to infections caused by bacteria such as Pasteurella multocida and Staphylococcus aureus, necessitating antibiotic treatment for both infected and at-risk wounds.

Effective management of bite wounds includes not only antibiotics like amoxicillin-clavulanate but also proper wound care through irrigation and debridement, with surgical repair being the preferred method for uninfected facial wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial bite wounds: management update. Stefanopoulos, PK., Tarantzopoulou, AD.[2005]

Citations

1.

aafp.org

aafp.org/pubs/afp/issues/2014/0815/p239.html

Dog and Cat Bites

Amoxicillin/clavulanate (Augmentin) is generally considered the first-line prophylactic treatment for animal bites.

2.

jmatonline.com

jmatonline.com/PDF/191-7_10380.pdf

Amoxicillin Versus Amoxicillin-Clavulanate for Prophylaxis ...

Conclusion: Amoxicillin can be used as a prophylactic antibiotic in dog and cat bite or scratch wounds, and there is no significant difference in infection rate ...

3.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK430852/

Animal Bites - StatPearls - NCBI Bookshelf - NIH

Amoxicillin-clavulanate is the preferred prophylactic antibiotic, with extended-spectrum cephalosporins recommended for patients who are ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213398424001908

Adherence to treatment in patients with animal bites in a ...

Adherence to antibiotic treatment was observed in 63 % of the patients. Signs and symptoms of infection occurred in 44 % of cases, while suture dehiscence ...

5.

trialx.com

trialx.com/clinical-trials/listings/238422/cat-bite-antibiotic-prophylaxis-for-the-handforearm-catbite/

CAT BITE Antibiotic Prophylaxis for the Hand/Forearm ...

Prophylactic antibiotics are often recommended with amoxicillin-clavulanate for 3-5 days to decrease the incidence of developing an infection.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11093789/

Cat bite injuries to the hand and forearm

Of the 102 patients, 90% suffered an isolated injury to the hand, 4% an isolated injury to the forearm, and 6% a combination of hand and forearm ...

7.

uptodate.com

uptodate.com/contents/human-bites-evaluation-and-management/abstract/1,2

Medline ® Abstracts for References 1,2 of 'Human bites

Infected bite wounds manifest with swelling, erythema, and tenderness with or without drainage of the affected site and can lead to serious complications. Most ...