Improving Safety of Antivenom in People Bitten by Snakes - Tabular View

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

Same as current

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Snake Bites

Intervention ^ICMJE

Drug: adrenaline, promethazine, hydrocortisone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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 ID ^ICMJE

NCT00270777

Responsible Party

Study ID Numbers ^ICMJE

178A07

Study Sponsor ^ICMJE

University of Kelaniya

Collaborators ^ICMJE

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