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

Phase 2

Recruiting

• Conditions: Centruroides Envenomation
• Interventions: Drug: Traditional scorpion antivenom regimen; Drug: Serial dose of scorpion antivenom regimen

• Registration Number: NCT06333834
• Lead Sponsor: Selene Guadalupe Huerta Olvera

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Study Start: 2024-06-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional scorpion antivenom regimen	Traditional scorpion antivenom regimen	Active/placebo comparator
Serial dose of scorpion antivenom regimen	Serial dose of scorpion antivenom regimen	-

Primary Outcome Measures

Name	Time	Method
Time to resolution of signs and symptoms	two and a half to five hours	Time to resolution of signs and symptoms from admission and from the estimated time of the sting
Serum venom concentration	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 Outcome Measures

Name	Time	Method
Mortality	two and a half to five hours	Mortality rate of each group
Length of intrahospital stay	two and a half to five hours	Time from patient admission to discharge due to patient improvement
Serum antivenom concentration	two and a half to five hours	Scorpion antivenom concentration at five minutes after administration, prior to secondary doses, and prior to discharge

Trial Locations

Locations (1)

Servicios Médicos Municipales de San Pedro Tlaquepaque.; 🇲🇽 Tlaquepaque, Jalisco, Mexico