Evaluating a new snake antivenom for treating snakebites
The Safety and Effectiveness of PANAF- Premium TM Snake Venom Antiserum-Pan Africa Administered As a Standard Treatment for Cases of Snakebites- a Phase IV Open Label Trial
This study is testing a new snake antivenom to see how safe and effective it is for people of all ages who have been bitten by snakes in sub-Saharan Africa.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 112 (estimated) |
| Sex | All |
| Sponsor | Premium Serums & Vaccines Pvt.Ltd. Industry-sponsored |
| Locations | 1 site (Garoua, North Region) |
| Trial ID | NCT06615960 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the safety and effectiveness of PANAF-Premium TM, a newly introduced snake antivenom approved by WHO for use in sub-Saharan Africa. The study aims to systematically collect data on adverse events and treatment outcomes following the administration of this antivenom in patients with snakebite envenomation. Participants will include individuals of any age and sex who present with signs of envenomation at designated study sites. The study will help to address the challenges of snakebite treatment in regions where effective antivenoms have been scarce.
Who should consider this trial
Good fit: Ideal candidates are patients of any age or sex who have a history of snakebites and show clinical signs of envenomation.
Not a fit: Patients who do not exhibit signs of envenomation or have no history of snakebites may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and reduce mortality rates from snakebites in affected populations.
How similar studies have performed: Other studies have shown success with similar antivenom treatments, but this specific approach is novel in the context of sub-Saharan Africa.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients of both sex and of any age, with history of snakebites/unknown bites received in study sites * 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 - Defining local and systemic envenomation 1. 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 2. 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. (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: * 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 * Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning * Participants with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial * Known or persistent abuse of medication, drugs or alcohol Others conditions may include evidence of clinically significant neurological, cardiac, pulmonary, hepatic or renal disease as far as can be assessed by history of participants, physical examination, and/or laboratory examinations. NB: Patient previously sensitized with equine antiserum such as Tetanus or Diphtheria antitoxin or patients having received treatment with adrenaline, antihistamine, or steroids 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.
Where this trial is running
Garoua, North Region
- Garoua Regional Hospital — Garoua, North Region, Cameroon (Recruiting)
Study contacts
- Study coordinator: Tatiana Djikeussi
- Email: chokokamfile@gmail.com
- Phone: +237655190562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.