Safety and Effectiveness of PANAF-Premium TM Snake Venom Antiserum As Standard Treatment for Snak… (NCT06615960) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness of PANAF-Premium TM Snake Venom Antiserum As Standard Treatment for Snakebites
Cameroon112 participantsStarted 2024-08-26
Plain-language summary
Snakebite envenomation (SBE) is a major public health problem in many developing countries. Standard snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa.
This is an open-label, Phase IV post-marketing surveillance study to collect safety and effectiveness data systematically following the administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following the administration of PANAF-Premium TM and its effectiveness for snakebite management. Epidemiological data will also be collected, along with information on the snake species typically responsible for bites in the North region of Cameroon, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will complement the international and national pool of pharmacovigilance data.
Who can participate
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
. Local envenomation- (I) Presence of bite marks with or without oozing of blood, blistering and change in color of skin.
. Systemic envenomation- (i) Neurotoxic syndrome- signs of neuro-paralysis like blurring of vision, double vision, difficulty in swallowing, sleepy feeling, drooping of head, slurring of speech and the voice may become indistinct with shallow breathing, ptosis, ataxia, respiratory paralysis and generalized flaccid paralysis.
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 is testing something called PANAF-Premium snake venom antiserum — how does this differ from whatever antivenom my treating team would normally use for my snakebite, and is the standard treatment already proven safe and effective for the type of snake involved?
2Since this trial is listed as 'Phase NA,' what does that mean for how much is already known about the safety profile of PANAF-Premium, and what kinds of side effects or allergic reactions to antivenom should I watch out for?
3The trial is actively recruiting right now — given the urgency of treating a snakebite, how quickly would I need to make a decision about enrolling, and would participating change how fast I receive treatment compared to standard care?
4The study is measuring both the safety and effectiveness of PANAF-Premium — can you walk me through what data has already been collected on this product, and how will my outcomes be monitored if I take part?
5If I choose not to join this trial, what is the standard antivenom treatment available to me right now, and is there any reason to think participating would be a better or worse option given my specific situation?
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.