protocolSection identificationModule nctId: NCT06333834, orgStudyIdInfo id: Dosis Seriada de Alacramyn, briefTitle: Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Selene Guadalupe Huerta Olvera, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Centruroides Envenomation, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 121, type: ESTIMATED, armsInterventionsModule interventions name: Traditional scorpion antivenom regimen, interventions name: Serial dose of scorpion antivenom regimen, outcomesModule primaryOutcomes measure: Time to resolution of signs and symptoms, primaryOutcomes measure: Serum venom concentration, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Length of intrahospital stay, secondaryOutcomes measure: Serum antivenom concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Servicios Médicos Municipales de San Pedro Tlaquepaque., city: Tlaquepaque, state: Jalisco, zip: 45560, country: Mexico, contacts name: Héctor A González-Ruiz, PhD Student, role: CONTACT, phone: +52 33 1787 9139, email: andresgonzru@gmail.com, contacts name: Selene G Huerta-Olvera, PhD, role: CONTACT, phone: +52 392 111 0753, email: selene.huerta@academicos.udg.mx, geoPoint lat: 20.64091, lon: -103.29327, hasResults: False