nctId: NCT06333834 id: Dosis Seriada de Alacramyn briefTitle: Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-08-01 date: 2024-08-30 date: 2024-03-27 date: 2024-03-27 name: Selene Guadalupe Huerta Olvera class: OTHER 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. conditions: Centruroides Envenomation studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 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 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 count: 121 type: ESTIMATED name: Traditional scorpion antivenom regimen name: Serial dose of scorpion antivenom regimen measure: Time to resolution of signs and symptoms measure: Serum venom concentration measure: Mortality measure: Length of intrahospital stay measure: Serum antivenom concentration sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Servicios Médicos Municipales de San Pedro Tlaquepaque. city: Tlaquepaque state: Jalisco zip: 45560 country: Mexico name: Héctor A González-Ruiz, PhD Student role: CONTACT phone: +52 33 1787 9139 email: andresgonzru@gmail.com name: Selene G Huerta-Olvera, PhD role: CONTACT phone: +52 392 111 0753 email: selene.huerta@academicos.udg.mx lat: 20.64091 lon: -103.29327 hasResults: False