Evaluation of Anti-venoms Serum in Africa (NCT03326492) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Anti-venoms Serum in Africa
Cameroon474 participantsStarted 2019-10-17
Plain-language summary
There is little or no assessment under real-use conditions of the efficacy and the tolerance in the short, medium and long term of the antivenoms currently on the market and used in the treatment of snake bites.
The main objective is to assess the short term tolerance (\< 2 hours post-injection) of the antivenom Inoserp Pan-Africa® (temporary market authorization) from Inosan laboratory currently available in Cameroon.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any patient over 5 years old (inclusive) visiting at a participating center for a snake bite with or without confirmed envenoming
* Informed consent to research
Exclusion Criteria:
* Patient refusal
* Under 5 year-old
* Antivenom serum administration before the arrival in the participating center
* History of severe allergic reactions to antivenom serum
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested something called Inoserp Pan-Africa® — can you tell me what that antivenom is, whether it's available where we are, and whether the tolerance data from this completed study changes how you'd use it in my care?
2Since this study focused on short-term tolerance, meaning how well patients' bodies initially handled the antivenom, what do we actually know so far about whether it worked to neutralize the venom, and are there longer-term safety results I should be aware of?
3This trial was done across Africa — does the type of snake involved in my bite match the snakes this antivenom was designed and tested against, and does that affect whether it would be appropriate for me?
4Now that this study is completed, has the data been published or reviewed anywhere, and should we wait to see those results before deciding on a treatment approach, or is time too critical for that?
5Are there other antivenoms with more established safety and effectiveness data that you'd consider first for my situation, or does what's known about Inoserp Pan-Africa® make it a reasonable option to discuss right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short term tolerance of the antivenom serum Inoserp Pan-Africa®