Efficacy of Amoxicillin/Clavulanic Acid Prophylaxis in Green Pit Viper Bites: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial, in Urban Settings.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200910009

Enrollment

148

Registered

2020-09-10

Start date

2020-08-27

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

green pit viper bite Snakebite, envenomation, wound infection, green pit viper, trimeresurus spp, antibiotic

Interventions

take placebo twice a day for 5 days ,take amoxicillin/clavulanic acid 1 gram twice a day for 5 days

Placebo Comparator Drug,Active Comparator Drug

Placebo,Amoxicillin/clavulanic acid

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Wound infection from green pit viper bite 7 days after bite Chi-square	—

Secondary

Measure	Time frame
types of organism from GPV bite infection 7 days after bite descriptive	—

Countries

Thailand

Contacts

Public ContactRittirak Othong

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

toppoter@yahoo.com66874955558

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026