Improving Safety of Antivenom in People Bitten by Snakes | NCT00270777

Studies
Improving Safety of Antivenom in People Bitten by Snakes

NCT00270777

Sponsor

University of Kelaniya

Status

Completed

Last Update Posted

Jun 5, 2008Estimated

Enrollment

1,000Estimated

Phase

Phase 4

Conditions

Snake Bites

Interventions

adrenaline, promethazine, hydrocortisone

Countries

Sri Lanka

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Dec 27, 2005

First Submission Date that Met QC Criteria

Dec 27, 2005

First Posted Date

Dec 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2008

Last Update Posted Date

Jun 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
adrenaline, promethazine, hydrocortisone	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of severe reactions to antivenom in the first 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Frequency of moderate & severe reactions to antivenom in the first 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asita de Silva	University of Kelaniya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Unit, University of Kelaniya		Ragama			Sri Lanka

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21572992	Derived	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.

ID	Term
D001733	Bites and Stings
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries

ID	Term
D004837	Epinephrine
D011398	Promethazine
D006854	Hydrocortisone

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals