Comparing two methods of scorpion antivenom treatment for scorpion stings
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
This study is testing two different ways of giving antivenom to see which one helps people with scorpion stings feel better faster.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 121 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Guadalajara Academic / other |
| Locations | 1 site (Tlaquepaque, Jalisco) |
| Trial ID | NCT06333834 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of two different regimens of scorpion antivenom therapy in patients diagnosed with scorpionism. One regimen administers varying doses based on severity, while the other uses a consistent dose for all patients showing symptoms of envenomation. The primary measure of success is the time taken for symptoms to resolve, alongside assessments of complications, adverse effects, and blood concentrations of venom and antivenom. The study aims to determine which approach provides better outcomes for patients affected by scorpion stings.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 or older who present with a diagnosis of scorpionism within two hours of being stung.
Not a fit: Patients with allergies to the study medications or those who have received prior treatment for scorpion stings may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for scorpion envenomation, enhancing recovery times and reducing complications.
How similar studies have performed: While there have been studies on scorpion antivenom, this specific dose-response comparison is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tlaquepaque, Jalisco
- Servicios Médicos Municipales de San Pedro Tlaquepaque. — Tlaquepaque, Jalisco, Mexico (Recruiting)
Study contacts
- Principal investigator: Héctor A González-Ruiz, PhD student — Centro Universitario de Ciencias de la Salud
- Study coordinator: Héctor A González-Ruiz, PhD student
- Email: andresgonzru@gmail.com
- Phone: +52 33 1787 9139
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.