Home » Trials » SLCTR/2016/015
A Phase II dose finding study in Hypnale spp with New Polyvalent Snake Antivenom (ICP-AVRI-UOP Sri Lanka polyspecific antivenom)
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SLCTR Registration Number
SLCTR/2016/015
Date of Registration
The date of last modification
Aug 24, 2019
Trial Status
Scientific Title of Trial
A Phase II dose finding study in Hypnale spp with New Polyvalent Snake Antivenom (ICP-AVRI-UOP Sri Lanka polyspecific antivenom)
Public Title of Trial
A dose finding study in Hump-nosed pit viper bites with new antivenom
Disease or Health Condition(s) Studied
Hypnale Spp Snakebites
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1182-7336
Any other number(s) assigned to the trial and issuing authority
ERC: 2015/EC/85 (Peradeniya)
What is the research question being addressed?
Is the new polyvalent snake antivenom (ICP-AVRI-UOP Sri Lanka polyspecific antivenom) safe and effective in hump nosed pit viper envenomation ?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
The study will be conducted in toxicology ward of Teaching hospital Peradeniya. Participants meeting inclusion/exclusion criteria will be allocated to treatment groups (dosing level) mentioned below,
Level 1: 2 vials of ICP- AVRI-UOP Sri Lankan new antivenom dissolved in 20ml of water for injection and diluted in 200 ml of 0.9% saline (220ml final volume)
Level 2: 5 vials of ICP- AVRI-UOP Sri Lankan new antivenom dissolved in 50ml of water for injection and diluted in 200 ml of 0.9% saline (250ml final volume)
Level 3: 7 vials of ICP- AVRI-UOP Sri Lankan new antivenom dissolved in 70ml of water for injection and diluted in 200ml of 0.9% saline (270ml final volume)
Level 4: 10 vials of ICP- AVRI-UOP Sri Lankan new antivenom dissolved in 100ml of water for injection and diluted in 200ml of 0.9% saline (300ml final volume)
Supportive care will be provided to all patients according to standard guidelines.
Inclusion criteria
Patients with selected clinical manifestations of envenoming by Hypnale spp. (swelling of the bitten limb with pain and/or blister formation).
Exclusion criteria
Primary outcome(s)
|
1.
1) Free venom concentration in blood serum |
[ Primary outcome will be measured at 6, 12, 18, 24 and 48 hours after the initiation of antivenom and daily until dischargeweeks after discharge from the hospital ] |
Secondary outcome(s)
|
1.
(1) Clotting factors concentrations (Activated partial thromboplastin time [aPTT] fibrinogen, X, V, VII, VIII, D-dimer) (2) Hematological parameters: Hemoglobin concentration, haematocrit, white cell count, platelet count (3) Urinary markers of acute kidney injury (Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1) (4) Surrogate markers of Myotoxicity as assessed by creatine kinase (CK) (5) Surrogate markers of Renal toxicity as assessed by Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1 and serum creatinine (6) Pain Score (using a visual analogue scale) (7) Duration of hospital stay |
[ Secondary outcomes 1-6 will be measured at 6, 12, 18, 24 and 48 hours after the initiation of antivenom and daily until discharge Secondary outcome 7 will be measured as the time of initiation of AVS to time of discharge from the hospital ] |
Target number/sample size
40 (10 in each dose level)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-07-13
Anticipated end date
2018-07-01
Date of first enrollment
2016-12-04
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
South Asian Clinical Toxicology Research Collaboration
Regulatory approvals
Status
Approved
Date of Approval
2016-02-16
Approval number
2015/EC/85
Details of Ethics Review Committee
| Name: | 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
