Improving Safety of Antivenom in People Bitten by Snakes

This study has been completed.

Sponsor:

Information provided by:

University of Kelaniya

ClinicalTrials.gov Identifier:

NCT00270777

First received: December 27, 2005

Last updated: June 4, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 27, 2005

Last Updated Date

June 4, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of severe reactions to antivenom in the first 48 hours

Original Primary Outcome Measures ^ICMJE

Any acute reaction to antivenom (mild, moderate, or severe) in the first 48 hours

Change History

Complete list of historical versions of study NCT00270777 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Improving Safety of Antivenom in People Bitten by Snakes

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Snake Bites

Intervention ^ICMJE

Drug: adrenaline, promethazine, hydrocortisone

Study Arm (s)

Not Provided

Publications *

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. Epub 2011 May 10.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1000

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sri Lanka

Administrative Information

NCT Number ^ICMJE

NCT00270777

Other Study ID Numbers ^ICMJE

178A07

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Kelaniya

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Asita de Silva

University of Kelaniya

Information Provided By

University of Kelaniya

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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