Clinical Trial of a new snake antivenom for the treatment of viper snake bites in Sindh.

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014070218314N1
• Date of registration: 2014-10-07
• Prospective Registration: Yes
• Primary sponsor: Department of health, Governement of Sindh
• Public title: Clinical Trial of a new snake antivenom for the treatment of viper snake bites in Sindh.
• Scientific title: Clinical Trials of new bivalent snake antivenom immunoglobulins (IgG) for the treatment of envenoming by medically important vipers in Sindh (Phase II study)
• Date of first enrolment: 2014-10-20
• Target sample size: 12
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/16643
• Study type: interventional
• Study design: Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Single arm dose finding study.
• Phase: 2-3

Countries of recruitment

Pakistan

Contacts

• Name: Professor Dr. Allah Bux Ghanghro Principal Scientific Consultant
• Affiliation: Institute of Biochemistry University of Sindh Jamshoro

• Name: Dr. Naeemul Haque Quraishi, Principal Investigator
• Affiliation: snake antivenom/antirabies serology lab, department of Health, Government of Sindh

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteris: Patient envenomed by Saw Scaled Viper (Echis carinatus Sochureki/ lundi) and Russell’s viper (Daboia Russelii/Daman/Koriala); Adult male or female (non-pregnant) above 18 years. Reached hospital within few hours (within 0-7 hours) of snake bite. However the late reaching patients will be treated according to provincial protocol of snakebite management without inclusion in the study; Snake specie is confirmed by identification of dead snake or the clinical observation of incoagulable blood, or when a description of snake is associated with symptoms and signs consistent with systemic envenoming by viper species such as incoagulable blood, spontaneous systemic bleeding, intravascular hemolysis, (pink plasma, anemia, hemoglobinuria), acute renal failure or oliguria; 20WBCT shows incoagulable blood; Patients show no early (anaphylactic) reaction within 10-30 minutes (itching, urticaria, fever, nausea, vomiting, tachycardia, hypotension, bronchospasm) on administration of 0.3ml of test ASV as initial dose; Patient or his/her legally acceptable representative able to understand the informed consent and enter into the study with their free will by signing the same.
Exclusion Criteria: Not willing to accept newly produced ASV as the core remedy; Debilitated patients and those with other chronic or complicating medical conditions, any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any CV disease; Subject with known hypersensitivity to horse (equine) or sheep (ovine) serum in the past (for example after treatment with equine anti-tetanus serum, equine anti-rabies serum or equine or ovine anti-venom) and those with a strong history of atopic diseases (especially severe asthma); Patients showing reaction to initial dose of test ASV; Patients with severe condition, acute renal failure, anuria, generalized rhabdomyolysis evident with myoglobinuria and haemoglobinuria; Pregnant women and patients under 18 years of age; not bitten by any medically important vipers of Sindh.
Exclusion criteria:

Age minimum: 18 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Toxic effect of snake venom

treatment of envenomation.
Toxic effect of snake venom

Intervention(s)

Treatment - Drugs

Test drug: Snake antivenom immunoglobulin (IgG)

Test drug: Snake antivenom immunoglobulin (IgG).

Primary Outcome(s)

Permenant restoration of blood coagulability. Timepoint: 6, 12, 18 and 24 hours after dosing. Method of measurement: measured through 20 minutes whole blood clotting test.

Secondary Outcome(s)

Early and late snake antivenom reactions. Timepoint: after test dose and ful initial dose patients will be monitored for early reaction while patients will be checked on weekly basis for next 24 days after dosing for late serum reaction. Method of measurement: through clinical sign and symptoms and adverse evnt monitoring.

Source(s) of Monetary Support

Department of health, Governement of Sindh

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committe of Peoples University of medical & health sciences for women Shaheed Benazir Abad.