Search / Trial NCT06615960

Safety and Effectiveness of PANAF-Premium TM Snake Venom Antiserum As Standard Treatment for Snakebites

Launched by PREMIUM SERUMS & VACCINES PVT.LTD. · Sep 25, 2024

Trial Information

Current as of December 30, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new snake antivenom called PANAF-Premium TM, which is approved for use in sub-Saharan Africa. The trial aims to gather important information about how well this antivenom works in treating snakebites, including any side effects that might occur after its use. Researchers will collect data from patients who have been bitten by snakes to understand the different types of snakebites, how severe they are, and how quickly patients recover after receiving treatment.

To be eligible for this trial, participants must be of any age and gender and have a history of snakebites or unknown bites. They should show signs of snake venom effects, such as swelling or bleeding. However, individuals with certain health issues, such as serious heart or kidney problems, or those taking specific medications, cannot participate. If someone joins the study, they can expect to receive the PANAF-Premium TM antivenom, and researchers will monitor their recovery closely. This study is important because it aims to improve snakebite treatment in regions where effective antivenom has been hard to find.

Gender

ALL

Eligibility 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.

Trial Officials

Khadillar

Study Director

Premuim serums

About Premium Serums & Vaccines Pvt.Ltd.

Premium Serums & Vaccines Pvt. Ltd. is a leading biopharmaceutical company dedicated to the research, development, and manufacture of high-quality serums and vaccines. With a commitment to advancing public health, the company leverages cutting-edge technology and rigorous scientific methodologies to create innovative solutions for infectious diseases and immune-related conditions. Premium Serums & Vaccines is focused on conducting clinical trials that adhere to the highest ethical standards and regulatory guidelines, ensuring the safety and efficacy of its products. Through strategic partnerships and a robust pipeline, the company aims to make significant contributions to global health initiatives and improve patient outcomes worldwide.

Locations

Garoua, North, Cameroon

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0