Phase 3 clinical trial for non-inferiority efficacy and safety evaluation of scorpion "Padra Serum Alborz antivenom" production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Efficacy and safety non-inferiority evaluation of "Padra Serum Alborz" vs "Razi Vaccine Serum Research Institute" scorpion antivenom productions
Design
Active control, double blind, two-armed, randomized clinical trial designed for 98 scorpion sting victims age of 2 to 60
Settings and conduct
Scorpion sting victims who arrived the Razi Hospital in Ahvaz, will be assessed about inclusion and exclusion criteria. The victims 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.
Participants/Inclusion and exclusion criteria
Inclusion: 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: 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
Intervention groups
Intervention group: Scorpion Antivenom Vial (Padra Serum Alborz Production)
Control group: Scorpion Antivenom Ampule (Razi Vaccine Serum Research Institute)
Main outcome variables
Proportion of victims with alleviation of systemic scorpion envenomation (12 hours after antivenom injection)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039672N1
Registration date:2019-01-28, 1397/11/08
Registration timing:registered_while_recruiting
Last update:2019-01-28, 1397/11/08
Update count:1
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Maryam Amini Pouya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
maryam.aminipooya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase 3 clinical trial for non-inferiority efficacy and safety evaluation of scorpion "Padra Serum Alborz antivenom" production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Public title
Efficacy and safety evaluation of "Padra Serum Alborz" vs "Razi Vaccine and Serum Research Institute" scorpion antivenom productions
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 2 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
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 presented in the study cite drug stock, have been labeled with the research label & the unique untitled code before initiation of the study.
After entrance of each victim, according to the randomization sequence, the specific antivenom will prepared by the nurse. So through the randomization process, concealment & blindness of victims, physicians & outcome assessor also be maintained.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the victim consent and according to the antivenom infusion by the nurse, the victim and physician won't be aware of the injected antivenom brand. Also the final results will be given to outcome assessor with untitled codes.
So we expected the blindness in victims, physicians and outcome assessor would be obtained properly.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan High Way
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.AJUMS.REC.1397.790
Health conditions studied
1
Description of health condition studied
Scorpion sting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Proportion of victims with alleviation of scorpion envenomation symptoms
Timepoint
2, 6 & 24 hours after antivenom injection
Method of measurement
Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosis
2
Description
The mean duration of scorpion envenomation symptoms alleviation