An Open Randomised Controlled Trial for Optimzing Antivenom Therapy Among Carpet Viper Envenomed Children in Northeastern Nigeria
Phase 4
- Conditions
- Injury, Occupational Diseases, Poisoning
- Registration Number
- PACTR202106915491232
- Lead Sponsor
- Venom Antivenom Research Project Bayero University Kano
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-Proportion who achieve restoration of blood clotting following 20WBCT at 6 hours and at 12 hours post antivenom administration<br>2-Proportion who develop features of early adverse reactions (EAR) post antivenom administration(s); patients will be actively observed for 60 minutes post administration<br><br>
- Secondary Outcome Measures
Name Time Method 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. <br>2-Length of hospital stay in days and hours will recorded<br>3-All patients who die or develop life threatening complications (e.g., limb amputation) will be recorded<br>4-Proportion who develop late serum reactions in all enrolled groups<br>5-ELISA measurements of venom antigen and antivenom antibody (or fragment) level<br>