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.
Willingness to participate in the study by signing the Informed Consent Form (ICF)
Presence of one or more signs of envenomation detected by clinical examination including positive clot test. Patient may present with one or more of following visible clinical signs and symptoms of snake envenomation being local or systemic -
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.
Participants not able to give consent
Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
Pre-existing renal disease, uncontrolled chronic obstructive airway disease, congestive heart failure or previous myocardial infarction and consumption of diuretics, anticoagulants and antiplatelet drugs have been causes for exclusion in a few earlier studies as these illnesses and medications could have altered the clinical and laboratory profile of patients with envenomation.
Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
The study will recruit participants with a history of snakebites or unknown bites showing signs of envenomation requiring Snake Antiserum. Participants will come from health districts in Mayo Oulo, Gashiga, Poli, and Garoua I, located in the North region of Cameroon. One facility in each district has been selected based on prior snakebite cases: Garoua Regional Hospital, Poli District Hospital, Mayo Oulo District Hospital, and Gashiga District Hospital. No specific gender ratio is required, as previous studies have shown no differences in treatment effectiveness or safety between genders.
Cohort
Prospective
Not listed
Safety of Panaf Premuim
Measured by the frequency and severity of the recorded Adverse events based on clinical evaluation using DAAD (Division of AIDS grading of AE) grading classification.
Safety of Panaf Premium
Measured by the factors associated with the occurrence of adverse events, assessed through clinical evaluation and review of concomitant medication.
Effectiveness of Panaf Premium
Measured by the number of days required to control toxicity, defined as the time in days to achieve reversal of a positive Whole Blood Clotting Test (WBCT) in cases of hemotoxic envenomation, and/or the time to reverse clinical signs and symptoms based on the African Society of Venimology's classification and grading of envenomation.
Effectiveness of Panaf Premium
Effectiveness will be measured by the average dose of snake antivenom administered and documented throughout the patient\'s follow-up, with complete recovery defined by the resolution of symptoms according to the African Society of Venimology\'s classification and grading system
Identification of Snake Species Responsible for Envenomation
This outcome will be assessed by identifying the snake species responsible for envenomation, based on the description provided by the patient, clinical evaluation, and, where available or laboratory analysis. The investigator will document the snake species involved using classification systems as per guidelines of the African Society of Venimology
Snake bite epidemiology
This outcome will be assessed by calculating the proportion of patients who present with envenomation, categorized by age, sex, and clinical syndrome (e.g., neurotoxic, hemotoxic, or cytotoxic). Data will be collected using patient demographic information, clinical assessments, and envenomation classification systems based on the African Society of Venimology guidelines.
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