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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00270777
Other study ID # 178A07
Secondary ID
Status Completed
Phase Phase 4
First received December 27, 2005
Last updated June 4, 2008
Start date March 2005
Est. completion date April 2008

Study information

Verified date June 2008
Source University of Kelaniya
Contact n/a
Is FDA regulated No
Health authority Sri Lanka: Ministry of Healthcare & Nutrition
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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)

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
adrenaline, promethazine, hydrocortisone


Locations

Country Name City State
Sri Lanka Clinical Trials Unit, University of Kelaniya Ragama

Sponsors (1)

Lead Sponsor Collaborator
University of Kelaniya

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of severe reactions to antivenom in the first 48 hours
Secondary Frequency of moderate & severe reactions to antivenom in the first 48 hours
See also
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Withdrawn NCT02694952 - Non-inferiority Trial of Two Snake Antivenoms in CAR (PAVES) N/A
Completed NCT04520282 - Hemostatic Variables In Snakebite Study
Completed NCT01864200 - Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation Phase 4
Completed NCT04470791 - Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom. N/A