Clinical trial of two new anti-snake venoms for the treatment of patients bitten by venomous snakes in Nigeria

Phase 2

Completed

• Conditions: Snake bite; Injury, Occupational Diseases, Poisoning; Toxic effect of contact with venomous animals

• Registration Number: ISRCTN01257358
• Lead Sponsor: Federal Ministry of Health (Nigeria)

Brief Summary

2010 results in https://pubmed.ncbi.nlm.nih.gov/20668549/ (added 30/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-12-28
• Study Start: 2009-02-18
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients of both sexes and all ages bitten by snakes provided that:
1. They had incoagulable blood as defined by 20 minutes whole blood clotting time, indicative in this area of systemic envenoming by E. ocellatus
2. They have been bitten within the previous 72 hours
3. They or their relatives give informed consent to admission, treatment and investigation

Exclusion Criteria

1. Patients who had received antisnake venom within the last 24 hours
2. Pregnant women
3. Patients with clinical features of severe envenoming (shock, massive bleeding, lateralising signs suggesting intracranial haemorrhage, etc.) who require urgent treatment with a large dose of anti-venom and resuscitation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current information as of 11/02/10:<br> Restoration of blood coagulability, measured 6 hours after the initial dose of antivenom is deemed the primary outcome and time point of main interest. Incoagulable blood, measured at baseline, is an eligibility criterion.<br> To ensure that restoration of blood coagulability at 6 hr is not transient followed by recurrent envenoming, it is also checked at 12, 18, 24 and 48 hours after the initial dose of antivenom.<br><br> Initial information at time of registration:<br> Blood coagulability, measured at baseline, 6, 12, 18, 24 and 48 hours after treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Anaphylactic reaction, measured immediately after treatment with anti-venom<br> 2. Pyrogenic reaction, measured immediately after treatment with anti-venom<br> 3. Late serum sickness, measured 2 weeks after discharge<br>