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

Pre-clinical and clinical assessment of new anti-venoms for the treatments of patients envenomed by the saw-scaled or carpet viper (Echis ocellatus) in northern Nigeria

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01257358

Enrollment

400

Registered

2009-02-18

Start date

2005-05-14

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Snake bite Injury, Occupational Diseases, Poisoning Toxic effect of contact with venomous animals

Interventions

EchiTAb™ Plus is produced by the Instituto Clodomiro Picado (ICP), University of Costa Rica in collaboration with the EchiTAb study group Nigeria/UK and Liverpool School of Tropical Medicine and Unive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Current information as of 11/02/10: 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. 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. Initial information at time of registration: Blood coagulability, measured at baseline, 6, 12, 18, 24 and 48 hours after treatment	—

Measure

Time frame

Current information as of 11/02/10: 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. 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. Initial information at time of registration: Blood coagulability, measured at baseline, 6, 12, 18, 24 and 48 hours after treatment

—

Secondary

Measure	Time frame
1. Anaphylactic reaction, measured immediately after treatment with anti-venom 2. Pyrogenic reaction, measured immediately after treatment with anti-venom 3. Late serum sickness, measured 2 weeks after discharge	—

Countries

Nigeria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026