Efficacy of Amoxicillin/Clavulanic Acid Prophylaxis in Green Pit Viper Bites: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial, in Urban Settings.
- Conditions
- green pit viper biteSnakebite,envenomation,wound infection,green pit viper,trimeresurus spp,antibiotic
- Registration Number
- TCTR20200910009
- Lead Sponsor
- Faculty of Medicine Vajira Hospital, Navamindradhiraj University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 148
I1. Ages>/= 18 years old
I2. Patients are bitten by a green pit viper and visit one of our 5 participating sites
I3. Elapsed time from bite to ED visit < 6 hours
I4. Each participant must have one of the 3 national medical care rights for treatment at one of the 5 participating hospitals in this study
I4.1. Universal health-care coverage Scheme (UCS) or Social Security Scheme (SSS)
I4.2. Civil Servant Medical Benefit Scheme
I4.3. If a participant has UCS at a hospital outside Bangkok and he/she wants to get a medical care at one of the participating sites.
E1. Allergic to Amoxicillin/Clavulanic Acid or Penicillin
E2. If the bite wounds are at high risks for infection such as wound manipulation by mouth sucking, applying herbal materials, etc.
E3. Immunocompromised host or taking immunosuppressive drugs
E4. Pregnant
E5. Having evidence of systemic infection and having compartment syndrome
E6. Hemorrhagic shock or unstable vital signs
E7. Taking any antibiotics within 7 days prior to the bite
E8. Lack of literacy in Thai language
E9. Unable to make own decision or unable to communicate with the research team
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound infection from green pit viper bite 7 days after bite Chi-square
- Secondary Outcome Measures
Name Time Method types of organism from GPV bite infection 7 days after bite descriptive