Protocol summary
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Study aim
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Non-inferiority evaluation of efficacy and safety of "Padra Serum Alborz" vs "Razi Vaccine Serum Research Institute" scorpion antivenom productions
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Design
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Active control, double blind, two-armed, randomized(1:1), phase 3 clinical trial designed for 98 scorpion sting victims age of 2 to 60
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Settings and conduct
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Scorpion sting victims who will refer to Razi hospital in Ahvaz, will be assessed for inclusion and exclusion criteria. Then they will be treated with antivenom and concomitant therapy based on the initial sings & symptoms of systemic envenomation. The victims will be reassessed 2, 6, 12 & 24 hours after first antivenom infusion in hospital. The serum sickness incidence will be evaluated after 7 & 14 days. The victim, physician and the outcome assessor are blinded about type of antivenom.
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Participants/Inclusion and exclusion criteria
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Inclusion: Scorpion sting victims age of 2 to 60; Arriving to hospital maximum 6 hours after scorpion sting; Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion
Exclusion: 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 breast feeding women
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Intervention groups
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Intervention group: Scorpion Antivenom Vial (Padra Serum Alborz Production)
Control group: Scorpion Antivenom Ampule (Razi Vaccine Serum Research Institute)
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Main outcome variables
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Alleviation of systemic scorpion envenomation (12 hours after antivenom injection)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180515039672N1
Registration date:
2019-01-28, 1397/11/08
Registration timing:
prospective
Last update:
2019-05-12, 1398/02/22
Update count:
1
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Registration date
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2019-01-28, 1397/11/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-10, 1397/10/20
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Expected recruitment end date
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2019-04-21, 1398/02/01
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Actual recruitment start date
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2019-02-06, 1397/11/17
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Actual recruitment end date
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2019-04-16, 1398/01/27
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Trial completion date
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2019-04-30, 1398/02/10
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Scientific title
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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
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Public title
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Efficacy and safety evaluation of "Padra Serum Alborz" vs "Razi Vaccine and Serum Research Institute" scorpion antivenom productions
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 2 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
98
Actual sample size reached:
98
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-26, 1397/11/06
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Ethics committee reference number
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IR.AJUMS.REC.1397.790
Health conditions studied
1
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Description of health condition studied
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Scorpion sting
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Proportion of victims with alleviation of scorpion envenomation symptoms
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Timepoint
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12 hours after antivenom infusion
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Method of measurement
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Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosis
Secondary outcomes
1
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Description
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The mean time of scorpion envenomation symptoms duration alleviation
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Timepoint
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24 hours after antivenom infusion
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Method of measurement
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The time recording
2
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Description
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The incidence of anaphylactic reactions
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Timepoint
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During the study time
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Method of measurement
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Reporting the incidence proportion
3
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Description
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The Serum Sickness incidence
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Timepoint
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During the study time
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Method of measurement
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Reporting the incidence proportion
4
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Description
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The incidence of any other adverse events
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Timepoint
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During the study time
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Method of measurement
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Reporting the incidence proportion
5
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Description
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Duration of the victims' hospitalization
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Timepoint
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During the study time
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Method of measurement
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The time recording
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Padra Serum Alborz Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available