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An Open Randomised Controlled Trial for Optimzing Antivenom Therapy Among Carpet Viper Envenomed Children in Northeastern Nigeria

Optimzing Antivenom Therapy Among Carpet Viper Envenomed Children in Northeastern Nigeria

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202106915491232
Enrollment
80
Registered
2021-06-21
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Injury, Occupational Diseases, Poisoning

Interventions

EchiTab ICP Plus antivenom

Sponsors

Venom Antivenom Research Project Bayero University Kano
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1- Children aged 12 months to 12 years 2- Availability of intravenous access 3- Mild to moderately envenomed patients 4- Presentation within 72 hours of bite

Exclusion criteria

Exclusion criteria: 1- Severely envenomed sick children that are or have: a. Collapsed or in unresponsive shock b. Grade III of the snakebite severity score c. Severe anaemia with packed cell volume (PCV) less than 12% d. Non-transient unconscious patients e. Patients with severe delayed gangrenous body part f. Suspicion of acute end-organ complications e.g., acute kidney injury (AKI) g. Other 2- Inability to obtain intravenous access for antivenom administration or blood collection 3- Children less than 12 months 4- Other severe co-morbidities

Design outcomes

Primary

MeasureTime frame
1-Proportion who achieve restoration of blood clotting following 20WBCT at 6 hours and at 12 hours post antivenom administration 2-Proportion who develop features of early adverse reactions (EAR) post antivenom administration(s); patients will be actively observed for 60 minutes post administration

Secondary

MeasureTime frame
1- The enrolled patients will be assessed for size of the bitten limb compared to the non-bitten limb pre-antivenom administration and thereafter daily. 2- Length of hospital stay in days and hours will recorded 3- All patients who die or develop life threatening complications (e.g., limb amputation) will be recorded 4- Proportion who develop late serum reactions in all enrolled groups 5- ELISA measurements of venom antigen and antivenom antibody (or fragment) level

Countries

Nigeria

Contacts

Public ContactHamza Muhammad

Associate Professor of Medicine

drhamza1020@ymail.com+2348035053139

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026