Cat BitePhase 4CATBITENCT05846399
CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)
A Phase 4 study testing Amoxicillin/clavulanate, Ciprofloxacin and Clindamycin in people with Cat Bite and Hand Injuries, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cat Bite, Hand Injuries, Arm Injury
- What is being tested?
- Amoxicillin/clavulanate, Ciprofloxacin and Clindamycin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 1 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 57Show fewer
- 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
- Cartilage-hair hypoplasia
- Chédiak-Higashi syndrome
- Chronic Granulomatous Disease (CGD)
- Common Variable Immunodeficiency (CVID)
- Complement Deficiencies
- Congenital Neutropenia Syndromes
- Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA4) Deficiency
- Cyclic neutropenia
- DiGeorge syndrome
- Dedicator Of Cytokinesis 8 (DOCK8) Deficiency
- GATA-binding protein 2 (GATA2) Deficiency
- Glycosylation Disorders with Immunodeficiency
- Hyper-Immunoglobulin E Syndromes (HIES)
- Hyper-Immunoglobulin M Syndromes
- Interferon Gamma, Interleukin 12 and Interleukin 23 Deficiencies
- Leukocyte Adhesion Deficiency (LAD) Types 1 and 2
- Lipopolysaccharide Responsive Beige-Like Anchor Protein (LRBA) Deficiency
- Phosphatidylinositol 3-kinase (PI3-Kinase) Disease
- Phospholipase C gamma 2 (PLCG2) associated Antibody Deficiency and Immune Dysregulation (PLAID)
- Severe Combined Immunodeficiency (SCID)
- Selective Immunoglobulin A (IgA) deficiency
- Signal transducer and activator of transcription 3 (STAT3) Dominant-Negative Disease
- STAT3 Gain-of-Function Disease
- Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome
- Wiskott-Aldrich Syndrome (WAS)
- X-Linked Agammaglobulinemia (XLA)
- X-Linked Lymphoproliferative Disease (XLP)
- X-linked magnesium transporter 1 (MAGT1) deficiency with increased susceptibility to Epstein-Barr virus (EBV) infection and N-linked glycosylation defect (XMEN) Disease
- Zeta-associated protein 70 (ZAP-70) deficiency
- Secondary
- Malnutrition
- Uncontrolled Diabetes mellitus
- Chronic uremia
- Genetic syndromes: trisomy 21
- Immunomodulatory, immunosuppressive drug therapy: corticosteroids, calcineurin inhibitors, cytotoxic agents
- Systemic lupus erythematosus
- Malignancy
- Active radiation therapy
- Bone marrow ablation
- Infectious diseases: human immunodeficiency virus (HIV) infection, Hepatitis
- Additional Primary and secondary immunodeficiencies can be found at the following link.
- https://www.merckmanuals.com/professional/immunology-allergic-disorders/immunodeficiency-disorders/overview-of-immunodeficiency-disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Kevin M Klifto, DO, PharmD, 573-884-8176, kmkdg2@health.missouri.edu
Stephen H Colbert, MD, 573-882-1792, ColbertS@health.missouri.edu
About this study
Official title: CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial
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.
Read the 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 >$850,000,000 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 (n=5) or identically appearing placebo (n=6). Four of six participants receiving placebo, but none of the five participants receiving oxacillin, developed a wound infection (P = 0.045).
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.
- Conditions
- Cat Bite, Hand Injuries, Arm Injury, Infection, Bacterial, Anti-bacterial Agents
- Being tested
- Amoxicillin/clavulanate, Ciprofloxacin, Clindamycin, Placebo (microcrystalline cellulose), Wound management
- Medical subject headings
- Hand Injuries, Arm Injuries, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin/clavulanateDrug
Also called Augmentin; Clavulin; Betacillin; Clavamox
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
CiprofloxacinDrug
Also called Cipro
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
ClindamycinDrug
Also called Cleocin
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
Placebo (microcrystalline cellulose)Other
Also called (C6H10O5)n
Placebo (microcrystalline cellulose) by mouth twice daily by mouth for 5 days
Wound managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (microcrystalline cellulose) | Placebo comparator | Placebo capsules by mouth twice daily x 5 days (5 days of placebo microcrystalline cellulose capsules) Receives: 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 Receives: 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 Receives: Drug: Amoxicillin/clavulanate; Drug: Ciprofloxacin; Drug: Clindamycin; Procedure: Wound management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
Secondary outcomes (6)
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
To compare QuickDASH scores between each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's disability following cat bites to the hand and/or forearm within 30 days. different time points. QuickDASH scores are measured on a scale of 0 to 100 (higher scores indicate increased patient-reported disability).
Measured: Day 30+/-2
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
To compare changes in QuickDASH scores between each study arm and within each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's disability following cat bites to the hand and/or forearm at different time points. QuickDASH scores are measured on a scale of 0 to 100 (higher scores indicate increased patient-reported disability).
Measured: Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
HAND Questionnaire (HAND-Q) scores
To compare HAND-Q scores between each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's quality of life following cat bites to the hand and/or forearm within 30 days. The HAND-Q is composed of independently functioning scales scored separately. To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. Items are summed to produce a total scale raw score. A conversion table is used to convert raw scores into a score that ranges from 0 (worst) to 100 (best). The conversion, which linearizes the scores, is based on the findings from the Rasch analysis. Higher scores for HAND-Q scales reflect a better outcome.
Measured: Day 30+/-2
Changes in HAND Questionnaire (HAND-Q) scores
To compare changes in HAND-Q scores between each study arm and within each study arm to determine the effect of antibiotic prophylaxis and duration on a patient's quality of life following cat bites to the hand and/or forearm at different time points. The HAND-Q is composed of independently functioning scales scored separately. To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. Items are summed to produce a total scale raw score. A conversion table is used to convert raw scores into a score that ranges from 0 (worst) to 100 (best). The conversion, which linearizes the scores, is based on the findings from the Rasch analysis. Higher scores for HAND-Q scales reflect a better outcome.
Measured: Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
Adverse effects
To compare adverse effects between each study arm to determine the adverse effects of antibiotic prophylaxis and duration on cat bites to the hand and/or forearm within 30 days.
Measured: Day 30+/-2
Changes in adverse effects
To compare changes in adverse effects between each study arm and within each study arm to determine the adverse effects of antibiotic prophylaxis and duration on cat bites to the hand and/or forearm at different time points.
Measured: Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Sep 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cat BiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Colbert, University of Missouri-Columbia
- Investigators
- Kevin M Klifto, DO, PharmD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846399
- Sponsor's protocol ID
- 2092043
- Acronym
- CATBITE
- Status last verified
- Oct 2025
- First submitted
- 12 Apr 2023
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with researchers who have not been approved as study members by the University of Missouri IRB
Publications
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
PubMed 8773720Sierakowski 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.
PubMed 30898824Bregman 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.
PubMed 22379219Kwo 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.
PubMed 20006917Benson 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.
PubMed 16516744Kennedy 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.
PubMed 25538130Talan 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.
PubMed 9887159Medeiros I, Saconato H. Antibiotic prophylaxis for mammalian bites. Cochrane Database Syst Rev. 2001;(2):CD001738. doi: 10.1002/14651858.CD001738.
PubMed 11406003Lloret 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.
PubMed 23813817Stevens 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.
PubMed 16231249Coburn 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.
PubMed 23403420Beasley 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.
PubMed 5660015Elenbaas 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.
PubMed 6696302
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial
- ClinicalTrials.gov ID
- NCT05846399
- Acronym / sponsor ID
- CATBITE / 2092043
- Conditions
- Cat Bite, Hand Injuries, Arm Injury, Infection, Bacterial, Anti-bacterial Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 >$850,000,000 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 (n=5) or identically appearing placebo (n=6). Four of six participants receiving placebo, but none of the five participants receiving oxacillin, developed a wound infection (P = 0.045).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo (microcrystalline cellulose) | Placebo comparator | Other: Placebo (microcrystalline cellulose), Procedure: Wound managementPlacebo capsules by mouth twice daily x 5 days (5 days of placebo microcrystalline cellulose capsules) |
| Antibiotic x 1 day | Active comparator | Drug: Amoxicillin/clavulanate, Drug: Ciprofloxacin, Drug: Clindamycin, Other: Placebo (microcrystalline cellulose), Procedure: Wound managementAmoxicillin-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 |
| Antibiotic x 5 days | Active comparator | Drug: Amoxicillin/clavulanate, Drug: Ciprofloxacin, Drug: Clindamycin, Procedure: Wound managementAmoxicillin-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (57 listed)
- Patients who present with active local or systemic infections
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin/clavulanateAlso: Augmentin; Clavulin; Betacillin; ClavamoxAmoxicillin-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 | Drug | Antibiotic x 1 day, Antibiotic x 5 days |
| CiprofloxacinAlso: CiproAmoxicillin-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 | Drug | Antibiotic x 1 day, Antibiotic x 5 days |
| ClindamycinAlso: CleocinAmoxicillin-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 | Drug | Antibiotic x 1 day, Antibiotic x 5 days |
| Placebo (microcrystalline cellulose)Also: (C6H10O5)nPlacebo (microcrystalline cellulose) by mouth twice daily by mouth for 5 days | Other | Antibiotic x 1 day, Placebo (microcrystalline cellulose) |
| Wound managementWound 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. | Procedure or surgery | Antibiotic x 1 day, Antibiotic x 5 days, Placebo (microcrystalline cellulose) |
Primary outcome
Incidence of infection
Time frame: Day 30+/-2
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.
Changes of the incidence of infection
Time frame: Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
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.
6 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
Time frame: Day 30+/-2
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
Time frame: Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
HAND Questionnaire (HAND-Q) scores
Time frame: Day 30+/-2
Changes in HAND Questionnaire (HAND-Q) scores
Time frame: Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
Adverse effects
Time frame: Day 30+/-2
Changes in adverse effects
Time frame: Day 0, Day 2; Day 7+/-2; Day 14+/-2; Day 30+/-2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Background: PubMed 8773720Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
- Background: PubMed 30898824Sierakowski 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.
- Background: PubMed 22379219Bregman 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.
- Background: PubMed 20006917Kwo 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.
- Background: PubMed 16516744Benson 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.
- Background: PubMed 25538130Kennedy 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.
- Background: PubMed 9887159Talan 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.
- Background: PubMed 11406003Medeiros I, Saconato H. Antibiotic prophylaxis for mammalian bites. Cochrane Database Syst Rev. 2001;(2):CD001738. doi: 10.1002/14651858.CD001738.
- Background: PubMed 23813817Lloret 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.
- Background: PubMed 16231249Stevens 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.
- Background: PubMed 23403420Coburn 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.
- Background: PubMed 5660015Beasley 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.
- Individual participant dataSharing planned: No. IPD will not be shared with researchers who have not been approved as study members by the University of Missouri IRB
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin M Klifto, DO, PharmD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin/clavulanate, Ciprofloxacin and Clindamycin in people with Cat Bite and Hand Injuries, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen H Colbert, MD (573-882-2277, ColbertS@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection (time frame: Day 30+/-2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846399, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.