Efficacy and safety evaluation of Padra Serum Alborz vs Razi Vaccine and Serum Research Institute scorpion antivenom productions

Phase 3

• Conditions: Scorpion sting.

• Registration Number: IRCT20180515039672N1
• Lead Sponsor: Padra Serum Alborz Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.