Improving Safety of Antivenom in People Bitten by Snakes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Snake Bites

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Controlled trial Snake bite Safety Antivenom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adrenaline, promethazine, hydrocortisone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Asita de Silva

Role: PRINCIPAL_INVESTIGATOR

University of Kelaniya

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Trials Unit, University of Kelaniya

Ragama, , Sri Lanka

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sri Lanka

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 21572992 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

178A07

Identifier Type: -

Identifier Source: org_study_id