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

07 Jun 2016

The date of last modification

Jan 29, 2019


View original TRDS



Application Summary


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)


Trial Details


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

  1. History of snake bite with Daboia russelii or Echis carinatus (by clinical manifestations/visual identification of the snake where possible)

  2. Evidence of systemic envenomation based on Ministry of Health/Sri Lanka Medical Association guidelines.


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. Early anaphylactic-like reactions (up to 04 hrs)
      i. Mild: pruritus and/or urticarial only
      ii. Severe: Gastrointestinal symptoms (vomiting, diarrhoea, colicky abdominal pain)
      iii. Bronchospasm, or fall in systolic blood pressure below 90 mmHg.

    2. Early Pyrogenic reactions (upto 4 hours): increase oral temperature 38°C or above with or without rigors

    3. Late serum sickness type antivenom reactions (2 weeks later): urticarial, pruritus, arthralgia, fever

    [
    1. Every 15 minutes during antivenom administration (for upto 1 hour) and every 30 minutes thereafter up to 4 hours.

    2. Every 15 minutes during antivenom administration (for upto 1 hour) and every 30 minutes thereafter up to 4 hours.

    3. 2 weeks after discharge from hospital

    ]

Secondary outcome(s)

    1. Blood coagulability [assessed by prothrombin time (PT) and International Normalized ratio (INR) and Whole Blood Clotting Test 20 min (WBCT20).
    2. Free venom concentration in blood serum
    3. Clotting factors concentrations (Activated partial thromboplastin time [aPTT] fibrinogen, X, V, VII, VIII, D-dimer)
    4. Hematological parameters: Hemoglobin concentration, haematocrit, white cell count, platelet count
    5. Urinary markers of acute kidney injury (NGAL, ?2-microglobulin, KIM)
    6. Myotoxicity as assessed by creatine kinase (CK)
    7. Renal toxicity as assessed by NGAL, 2-microglobulin, KIM and serum creatinine
    8. Duration of hospital stay
    9. Duration of mechanical ventilation.
    10. Requirements for repeated dosing of antivenom
    11. Requirements for fresh frozen plasma (FFP)
    12. Requirements for packed red cells or platelets
    [

    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



State of Ethics Review Approval


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 & 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