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NCT Number: NCT06333834

Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism

The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated.

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Key information

Conditions

Centruroides Envenomation Bites and Stings Chemically-Induced Disorders Poisoning Scorpion Stings Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Servicios Médicos Municipales de San Pedro Tlaquepaque.

Tlaquepaque, Jalisco, 45560, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18 or older presenting with a diagnosis of scorpionism to the emergency department.
  • Treated solely with paracetamol, scorpion antivenom, saline solution, and local ice application.
  • Any gender.
  • Less than two hours elapsed since scorpion sting.
  • Willing to participate in the study through written informed consent.

Exclusion criteria

  • Allergies or contraindications to any of the study medications.
  • Uncertainty regarding scorpion sting.
  • Previous treatment by another physician.
  • Intramuscular administration of scorpion antivenom due to urgent clinical conditions.
  • Decision not to provide informed consent.
  • Any limitations hindering the proper understanding of study participation.

Treatment and study plan

Traditional scorpion antivenom regimen

Drug

All patients will be classified according to two severity scales. The pharmacist, who is the only team member aware of which group each patient was assigned to, will consider the classification corresponding to the classification proposed by the Mexican Clinical Practice Guideline to decide the dose of scorpion antivenom. Scorpion antivenom will be administered to all patients. Patients in this group will receive between one and three vials every 30 minutes, depending on the severity of the condition (one vial for patients classified as grade I, two vials for patients classified as grade II, and three vials for patients classified as grade III)

Serial dose of scorpion antivenom regimen

Drug

All patients will be classified according to two severity scales. The pharmacist, who is the only team member aware of which group each patient was assigned to, will consider the classification corresponding to the American classification to decide the dose of scorpion antivenom. Scorpion antivenom will be administered only in the presence of signs and/or systemic symptoms of intoxication, excluding signs and symptoms at the sting site. Patients in this group will receive between one and two vials every 30 minutes, depending on the severity of the condition (one vial for patients classified as grade III and two vials for patients classified as grade IV)

Primary outcomes

  1. Time to resolution of signs and symptoms

    Time frame: two and a half to five hours

    Time to resolution of signs and symptoms from admission and from the estimated time of the sting

  2. Serum venom concentration

    Time frame: two and a half to five hours

    Serum venom concentration upon patient arrival, after administration of antivenom, and upon reporting the absence of signs of intoxication

Secondary outcomes

  1. Mortality

    Time frame: two and a half to five hours

    Mortality rate of each group

  2. Length of intrahospital stay

    Time frame: two and a half to five hours

    Time from patient admission to discharge due to patient improvement

  3. Serum antivenom concentration

    Time frame: two and a half to five hours

    Scorpion antivenom concentration at five minutes after administration, prior to secondary doses, and prior to discharge

Sponsors and collaborators

Lead sponsor

Selene Guadalupe Huerta Olvera

Other

Registry information

Official study title

Assessment of the Efficacy of Anti-scorpion Venom Therapy in a Dose-response Manner, Following the Principles of Rational Drug Use in Patients With Scorpionism: a Non-inferiority, Randomized, Double-blind, Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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