An observational study in Snake Bites, sponsored by Premium Serums & Vaccines Pvt.Ltd.. Recruiting at 1 site in Cameroon. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Premium Serums & Vaccines Pvt.Ltd. · Observational
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.
Background: Snakebite envenomation (SBE) is a major public health problem in many developing countries. Conventional 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 the latest standards, providing a solution 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. Since antivenom is of animal origin, it can cause adverse reactions ranging from mild itching to fatal anaphylaxis; therefore, patients should be treated appropriately or given prophylactic premedication. Approximately 20% of cases may develop early (within a few hours) or late (five days or more) allergic reactions after administration of snake antivenom. This open-label, Phase IV post-marketing surveillance study aims to collect safety and effectiveness data systematically following administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following administration of PANAF-Premium TM and its effectiveness for snakebite management. Additionally, epidemiological data will be collected regarding the snake species typically responsible for bites in the North Cameroon region, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will also contribute to the international and national pool of pharmacovigilance data.
Method: An open-label, Phase IV post-marketing surveillance trial will be conducted to describe the types, severity, and number of adverse events recorded during snakebite management. The average dose of SA used will be identified, and the duration of recovery, as well as the type of snakes prevalent in the area, will be explored. Eligible patients will be admitted to the hospital, and case management will be in accordance with the standard protocol followed in Cameroon and adapted from the guidelines of the African Society of Venomology. Any medication or procedure necessary to save the patient will be permitted. If antivenom serum is needed, the study drug to be used is PANAF-Premium TM (Snake Venom Antiserum-Pan Africa), manufactured by Premium Serums \& Vaccines Pvt. Ltd. Any suspicious or unexpected serious adverse events (SAEs) will be recorded immediately and reported to the sponsor/ethics committee for further action. There will be no restrictions on the use of any concomitant medication or other interventions or investigations mandated by the patient\'s clinical condition.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's planned enrollment of 112 is above the median of 99 across 19 observational studies indexed under Snake Bites.
Browse Snake Bites studies →This is the only study on the registry with Premium Serums & Vaccines Pvt.Ltd. as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients of both sex and of any age, with history of snakebites/unknown bites received in study sites
Defining local and systemic envenomation
Local envenomation- (I) Presence of bite marks with or without oozing of blood, blistering and change in color of skin.
(ii) Rapidly progressive or massive swelling involving more than half of the bitten limb within few hours of bite (without tourniquet) (iii) Development of enlarged tender lymph nodes draining the bitten part within couple of hours after bite
(ii) Hemotoxic syndrome- spontaneous systemic bleeding, nausea, vomiting, abdominal pain and abdominal tenderness suggestive of gastro-intestinal or retro-peritoneal bleed and/or renal damage, coagulopathy detected by 20 min WBCT with or without external bleeding and shock and a clinical condition/envenomation serious enough to administer SA will be eligible for enrolment
Exclusion Criteria:
NB: Patient previously sensitized with equine antiserum such as Tetanus or Diphtheria antitoxin or patients having received treatment with adrenaline, antihistamine, or as a part of treatment at primary health care center and pregnancy will not be excluded. Since this is a post-marketing study, these patients will be included, and this information will be factored in while collating and analyzing data.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 30 days
Safety of Panaf Premium
Measured by the factors associated with the occurrence of adverse events, assessed through clinical evaluation and review of concomitant medication.
Time frame: 30 days
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.
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: Undecided — This has not yet been decided for the moment
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