Improving Safety of Antivenom in People Bitten by Snakes

NCT00270777 | Completed Phase 4 DMC

• 1 other identifier: 178A07
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, \& hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.

Conditions

Snake Bites

Keywords

Controlled trial; Snake bite; Safety; Antivenom

Outcome Measures

Primary Outcomes (1)

• Frequency of severe reactions to antivenom in the first 48 hours

Secondary Outcomes (1)

• Frequency of moderate & severe reactions to antivenom in the first 48 hours

Interventions

adrenaline, promethazine, hydrocortisone DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 12 years of age
• Patients admitted to hospital after snake bite in whom antivenom is indicated
• Patients who give informed consent

You may not qualify if:

• Patients who are pregnant or nursing
• Patients who are currently taking beta- or alpha-adrenoceptor antagonists, or tricyclic antidepressants
• Patients in whom adrenaline may be contraindicated (this may include patients with the following: history of ischaemic heart disease, stroke, uncontrolled hypertension, and tachyarrhythmias)

Sponsors & Collaborators

• University of Kelaniya: lead

Study Sites (1)

Clinical Trials Unit, University of Kelaniya

Ragama, Sri Lanka

Location

Related Publications (1)

• de Silva HA, Pathmeswaran A, Ranasinha CD, Jayamanne S, Samarakoon SB, Hittharage A, Kalupahana R, Ratnatilaka GA, Uluwatthage W, Aronson JK, Armitage JM, Lalloo DG, de Silva HJ. Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 May;8(5):e1000435. doi: 10.1371/journal.pmed.1000435. Epub 2011 May 10.

  PMID: 21572992 DERIVED

MeSH Terms

Conditions

Snake Bites

Interventions

Epinephrine; Promethazine; Hydrocortisone

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propylamines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Asita de Silva

  University of Kelaniya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 28, 2005
• Study Start: March 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 5, 2008

Record last verified: 2008-06

Locations

SR (1)