Centruroides EnvenomationPhase 2/3NCT06333834
Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism
A Phase 2/3 study testing Traditional scorpion antivenom regimen and Serial dose of scorpion antivenom regimen in people with Centruroides Envenomation, run by Selene Guadalupe Huerta Olvera at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Centruroides Envenomation
- What is being tested?
- Traditional scorpion antivenom regimen and Serial dose of scorpion antivenom regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jun 2024to 1 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Servicios Médicos Municipales de San Pedro Tlaquepaque.
Tlaquepaque, Jalisco, 45560
About this study
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
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.
- Conditions
- Centruroides Envenomation
- Being tested
- Traditional scorpion antivenom regimen, Serial dose of scorpion antivenom regimen
- Keywords
- Centruroides, Antivenom, Scorpion antivenom, Scorpion envenomation
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional scorpion antivenom regimenDrug
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 regimenDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Traditional scorpion antivenom regimen | Active comparator | Active/placebo comparator Receives: Drug: Traditional scorpion antivenom regimen |
| Serial dose of scorpion antivenom regimen | Experimental | Not described Receives: Drug: Serial dose of scorpion antivenom regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of signs and symptoms
Time to resolution of signs and symptoms from admission and from the estimated time of the sting
Measured: two and a half to five hours
Serum venom concentration
Serum venom concentration upon patient arrival, after administration of antivenom, and upon reporting the absence of signs of intoxication
Measured: two and a half to five hours
Secondary outcomes (3)
Mortality
Mortality rate of each group
Measured: two and a half to five hours
Length of intrahospital stay
Time from patient admission to discharge due to patient improvement
Measured: two and a half to five hours
Serum antivenom concentration
Scorpion antivenom concentration at five minutes after administration, prior to secondary doses, and prior to discharge
Measured: two and a half to five hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Jun 2024
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Centruroides EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selene Guadalupe Huerta Olvera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selene Guadalupe Huerta Olvera, University of Guadalajara
- Investigators
- Selene G Huerta-Olvera, PhD, Study director, Medical & Life Sciences Department. La Ciénega University CenterHéctor A González-Ruiz, PhD student, Principal investigator, Centro Universitario de Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333834
- Sponsor's protocol ID
- Dosis Seriada de Alacramyn
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06333834
- Acronym / sponsor ID
- Dosis Seriada de Alacramyn
- Conditions
- Centruroides Envenomation
- Keywords
- Centruroides, Antivenom, Scorpion antivenom, Scorpion envenomation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Selene Guadalupe Huerta OlveraUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Traditional scorpion antivenom regimen | Active comparator | Drug: Traditional scorpion antivenom regimenActive/placebo comparator |
| Serial dose of scorpion antivenom regimen | Experimental | Drug: Serial dose of scorpion antivenom regimen |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional scorpion antivenom regimenAll 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) | Drug | Traditional scorpion antivenom regimen |
| Serial dose of scorpion antivenom regimenAll 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) | Drug | Serial dose of scorpion antivenom regimen |
Primary outcome
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
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
3 secondary outcomes
Mortality
Time frame: two and a half to five hours
Length of intrahospital stay
Time frame: two and a half to five hours
Serum antivenom concentration
Time frame: two and a half to five hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Results publication: PubMed 27487782Coorg 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Traditional scorpion antivenom regimen and Serial dose of scorpion antivenom regimen in people with Centruroides Envenomation, run by Selene Guadalupe Huerta Olvera at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of signs and symptoms (time frame: two and a half to five hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.