CClinicalTrials.gg
CompletedNCT06333834Updated Dec 17, 2025

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

A Phase 2/3 interventional study of Traditional scorpion antivenom regimen and Serial dose of scorpion antivenom regimen in Centruroides Envenomation, sponsored by Selene Guadalupe Huerta Olvera. Completed at 1 site in Mexico. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Selene Guadalupe Huerta Olvera · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Centruroides Envenomation

Keywords

  • Centruroides
  • Antivenom
  • Scorpion antivenom
  • Scorpion envenomation
03

In context

Lead sponsor

This is the only study on the registry with Selene Guadalupe Huerta Olvera as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Traditional scorpion antivenom regimen

    Active/placebo comparator

    Drug: Traditional scorpion antivenom regimen

  • Experimental
    Serial dose of scorpion antivenom regimen

    Drug: Serial dose of scorpion antivenom regimen

Interventions

  • DrugTraditional scorpion antivenom regimen

    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)

  • DrugSerial dose of scorpion antivenom regimen

    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)

06

What researchers measure

Primary outcomes

  1. Time to resolution of signs and symptoms

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

    Time frame: two and a half to five hours

  2. Serum venom concentration

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

    Time frame: two and a half to five hours

Secondary outcomes

  1. Mortality

    Mortality rate of each group

    Time frame: two and a half to five hours

  2. Length of intrahospital stay

    Time from patient admission to discharge due to patient improvement

    Time frame: two and a half to five hours

  3. Serum antivenom concentration

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

    Time frame: two and a half to five hours

07

Study locations

1 site
  • Servicios Médicos Municipales de San Pedro Tlaquepaque.
    Tlaquepaque, Jalisco 45560, Mexico
08

References and documents

Publications

  • 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. PubMed 27487782 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06333834
Lead sponsor
Selene Guadalupe Huerta Olvera
Responsible party
Selene Guadalupe Huerta Olvera (Professor and researcher, University of Guadalajara) — Sponsor-investigator
First posted
Mar 27, 2024
Start date
Jun 15, 2024
Primary completion
Nov 1, 2025
Completion
Dec 1, 2025
Last update
Dec 17, 2025

Study contacts

Selene G Huerta-Olvera, PhD
study director · Medical & Life Sciences Department. La Ciénega University Center
Héctor A González-Ruiz, PhD student
principal investigator · Centro Universitario de Ciencias de la Salud

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion