Clinical trial NCT06333834: Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Centruroides Envenomation
Keywords: Centruroides
Antivenom
Scorpion antivenom
Scorpion envenomation
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy in a reduced regimen. The dosing regimen based on response will be one initial intravenous vial in patients with grade III scorpion envenomation, and two initial intravenous vials as the starting dose in patients with grade IV scorpion envenomation, according to the FDA classification of scorpion envenomation. In both scenarios, an additional vial can be administered every 30 minutes if symptoms persist, with no limit on vials. Control Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy according to the traditional regimen proposed in the Mexican Clinical Practice Guideline, where, according to the severity classification of scorpion envenomation, between one and six vials of anti-scorpion venom will be administered, and equal doses can be repeated every 30 minutes if necessary.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to resolution of signs and symptoms
timeFrame: two and a half to five hours
measure: Serum venom concentration
timeFrame: two and a half to five hours
Secondary outcomes:
measure: Mortality
timeFrame: two and a half to five hours
measure: Length of intrahospital stay
timeFrame: two and a half to five hours
measure: Serum antivenom concentration
timeFrame: two and a half to five hours
Other outcomes:
Locations:
city: Tlaquepaque
country: Mexico
facility: Servicios Médicos Municipales de San Pedro Tlaquepaque.
state: Jalisco
Study officials:
affiliation: Medical & Life Sciences Department. La Ciénega University Center
name: Selene G Huerta-Olvera, PhD
role: STUDY_DIRECTOR
affiliation: Centro Universitario de Ciencias de la Salud
name: Héctor A González-Ruiz, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coorg V, Levitan RD, Gerkin RD, Muenzer J, Ruha AM. Clinical Presentation and Outcomes Associated with Different Treatment Modalities for Pediatric Bark Scorpion Envenomation. J Med Toxicol. 2017 Mar;13(1):66-70. doi: 10.1007/s13181-016-0575-3. Epub 2016 Aug 3.