Home » Trials » SLCTR/2016/012
A Randomized controlled trial on the safety of ICP-AVRI-UOP Sri Lankan polyspecific antivenom compared to Indian AVS in patients with snakebite
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SLCTR Registration Number
SLCTR/2016/012
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Scientific Title of Trial
A Randomized controlled trial on the safety of ICP-AVRI-UOP Sri Lankan polyspecific antivenom compared to Indian AVS in patients with snakebite
Public Title of Trial
A study of the safety of a Sri Lankan antivenom compared to Indian antivenom in patients with snakebite
Disease or Health Condition(s) Studied
Daboia russelii and Echis carinatus snakebite
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1180-0508
Any other number(s) assigned to the trial and issuing authority
2015/EC/85 (ERC Peradeniya)
What is the research question being addressed?
Is the new polyvalent snake antivenom (ICP-AVRI-UOP Sri Lanka polyspecific antivenom) superior in terms of safety when compared to Indian polyvalent snake antivenom?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
Phase III RCT (patients with Daboia russelii or Echis carinatus bites)
The study will be conducted in medical wards of collaborating hospitals. Participants meeting inclusion/exclusion criteria will be allocated to treatment arms using simple sealed envelopes specifying the randomly allocated treatment. Participants at each collaborating hospital will be randomized 1:1 to receive one of the below treatment arms,
Arm 01: Intervention arm will receive 10 vials of ICP-AVRI-UOP Sri Lanka administered according to standard guidelines (Ministry of Health/SLMA snakebite management guidelines)
Arm 02: Control arm will receive 10 vials of Indian antivenom (AVS) administered according to standard guidelines (Ministry of Health/SLMA snakebite management guidelines)
Supplementary Treatment with additional doses of antivenom or FFP will be provided to both arms based on the standard guidelines.
Inclusion criteria
History of snake bite with Daboia russelii or Echis carinatus (by clinical manifestations/visual identification of the snake where possible)
Evidence of systemic envenomation based on Ministry of Health/Sri Lanka Medical Association guidelines.
Exclusion criteria
Primary outcome(s)
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1.
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[
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Secondary outcome(s)
|
1.
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[ Secondary outcomes 1-7 will be measured at 6, 12, 18, 24 and 48 hours after the initial dose of antivenom Secondary outcome 8 will be measured as the time of initiation of AVS to time of discharge from the hospital Secondary outcome 9 measured from the time of initiation of mechanical ventilation until extubation Secondary outcomes 10-12 will be measured at 6 hours post treatment ] |
Target number/sample size
220 (110 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-03-01
Anticipated end date
2021-03-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
South Asian Clinical Toxicology Research Collaboration
Regulatory approvals
Status
Approved
Date of Approval
2016-02-11
Approval number
2015/EC/85
Details of Ethics Review Committee
| Name: | 6. Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Professor Indika Bandara Gawarammana
Professor in Medicine
Head of the department, Department of Medicine, Faculty of Medicine,University of Peradeniya, Peradeniya
+94814479822
+94714225081
+94814479822
indikagaw@gmail.com
Contact Person for Public Queries
Mr. Seyed Shahmy
Manager Operations
SACTRC, Faculty of Medicine
University of Peradeniya, Peradeniya
+94812387992
+94773938949
+94814479822
shahmy@sactrc.org
Primary study sponsor/organization
South Asian Clinical Toxicology Research Collaboration
SACTRC, Faculty of Medicine
University of Peradeniya, Peradeniya
+94814479822
+94814479822
enquiry@sactrc.org
www.sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
