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

15 Jun 2016

The date of last modification

Jan 29, 2019



Application Summary


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)


Trial Details


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

  1. <14 years of age
  2. Pregnancy
  3. Already received antivenom, fresh frozen plasma (FFP), or pre-medication such as adrenaline, hydrocortisone or promethazine at the primary hospital
  4. History of allergy to antivenom
  5. Inability to give direct or proxy consent (unconscious and unaccompanied by a relative)
  6. Presentation more than 8 hours after snake bite.


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

2016-10-18


Date of study completion


Recruitment status

Recruiting


Funding source

South Asian Clinical Toxicology Research Collaboration


Regulatory approvals



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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