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IRCT20180515039672N1 IRCT 2019-01-28 Padra Serum Alborz Company Efficacy and safety evaluation of "Padra Serum Alborz" vs "Razi Vaccine and Serum Research Institute" scorpion antivenom productions Phase 3 clinical trial for non-inferiority evaluation of efficacy and safety of scorpion antivenom "Padra Serum Alborz " production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60 2019-01-10 anticipated 98 Complete https://irct.ir/trial/35867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization sequences will be made by online software using the quadruple blocks before the start of study to achieve the sample size of 98 victims. Each of these sequences will be converted to untitled code (e.g. c45, a37, ...). Antivenoms that will be presented in the study cite drug stock, have been labeled with the research label & the unique untitled code before initiation of the study. After arrival of each victim, according to the randomization sequence, the specific antivenom will be prepared by the nurse. So through the randomization process, concealment & blindness of victims, physicians & outcome assessor also would be kept, Blinding description: After the victim consent and according to the antivenom infusion by the nurse, the victim and physician will not be aware of the injected antivenom brand. Also the final results will be given to outcome assessor with untitled codes. So we would expect that the blindness in victims, physicians and outcome assessor will be obtained properly. 3 Scorpion sting. Intervention 1: Intervention group: 1 to 3, 5ml vials (by physician diagnosis based on initial signs) of Scorpion Antivenom (Padra Serum Alborz Production) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion. Intervention 2: Control group: 1 to 3, 5ml ampules (by physician diagnosis based on initial signs) of Scorpion Antivenom (Razi Vaccine and Serum Research Institute) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion Scorpion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information exists
public Maryam Amini Pouya
No. 110, Khaje Nasir Tousi St., Bahman St,. Sepehr Industrial Town.
Nazar Abad Iran (Islamic Republic of) 3331495894 +98 26 4533 4189 m.amini@artapharmed.com Padra Serum Alborz scientific Ahmad Ghorbani
Razi Hospital, Felestin St., Amanie
Ahvaz Iran (Islamic Republic of) 3318461357 +98 61 3161 ahmadghorbanidr@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Scorpion sting victims age of 2 to 60 Hospital entrance at maximum 6 hours after scorpion sting Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion 2 years 60 years Both History of allergic reactions to plasma derived productions History of severe allergic diseases such as atopic asthma Present of systemic diseases such as cardiovascular and kidney diseases Pregnant and nursing women Treatment - Drugs Treatment - Drugs Intervention group: 1 to 3, 5ml vials (by physician diagnosis based on initial signs) of Scorpion Antivenom (Padra Serum Alborz Production) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion Control group: 1 to 3, 5ml ampules (by physician diagnosis based on initial signs) of Scorpion Antivenom (Razi Vaccine and Serum Research Institute) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion Scorpion Proportion of victims with alleviation of scorpion envenomation symptoms. Timepoint: 12 hours after antivenom infusion. Method of measurement: Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosis. The mean time of scorpion envenomation symptoms duration alleviation. Timepoint: 24 hours after antivenom infusion. Method of measurement: The time recording. The incidence of anaphylactic reactions. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion. The Serum Sickness incidence. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion. The incidence of any other adverse events. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion. Duration of the victims' hospitalization. Timepoint: During the study time. Method of measurement: The time recording. Padra Serum Alborz Company Approved 2019-01-26 Ahvaz Jundishapur University of Medical Sciences Golestan High Way Ahvaz Khouzestan Iran (Islamic Republic of)