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

NCT06615960 | Recruiting

• 1 other identifier: PMS1001
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Snake Bites

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  30 days

Secondary Outcomes (2)

• Identification of Snake Species Responsible for Envenomation

  6 months

• Snake bite epidemiology

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• Participants not able to give consent
• Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
• 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.

Sponsors & Collaborators

• Premium Serums & Vaccines Pvt.Ltd.: lead

Study Sites (1)

Garoua Regional Hospital

Garoua, North Region, Cameroon

RECRUITING

Related Publications (8)

• Gutierrez JM, Calvete JJ, Habib AG, Harrison RA, Williams DJ, Warrell DA. Snakebite envenoming. Nat Rev Dis Primers. 2017 Sep 14;3:17063. doi: 10.1038/nrdp.2017.63.

  PMID: 28905944 BACKGROUND

• Visser LE, Kyei-Faried S, Belcher DW. Protocol and monitoring to improve snake bite outcomes in rural Ghana. Trans R Soc Trop Med Hyg. 2004 May;98(5):278-83. doi: 10.1016/S0035-9203(03)00065-8.

  PMID: 15109550 BACKGROUND

• Schiermeier Q. Africa braced for snakebite crisis. Nature. 2015 Sep 17;525(7569):299. doi: 10.1038/525299a. No abstract available.

  PMID: 26381961 BACKGROUND

• Chippaux JP, Habib AG. Antivenom shortage is not circumstantial but structural. Trans R Soc Trop Med Hyg. 2015 Dec;109(12):747-8. doi: 10.1093/trstmh/trv088. No abstract available.

  PMID: 26626337 BACKGROUND

• Brown NI. Consequences of neglect: analysis of the sub-Saharan African snake antivenom market and the global context. PLoS Negl Trop Dis. 2012;6(6):e1670. doi: 10.1371/journal.pntd.0001670. Epub 2012 Jun 5.

  PMID: 22679521 BACKGROUND

• Gutierrez JM. Global Availability of Antivenoms: The Relevance of Public Manufacturing Laboratories. Toxins (Basel). 2018 Dec 24;11(1):5. doi: 10.3390/toxins11010005.

  PMID: 30586868 BACKGROUND

• Potet J, Smith J, McIver L. Reviewing evidence of the clinical effectiveness of commercially available antivenoms in sub-Saharan Africa identifies the need for a multi-centre, multi-antivenom clinical trial. PLoS Negl Trop Dis. 2019 Jun 24;13(6):e0007551. doi: 10.1371/journal.pntd.0007551. eCollection 2019 Jun.

  PMID: 31233536 BACKGROUND

• Habib AG, Warrell DA. Antivenom therapy of carpet viper (Echis ocellatus) envenoming: effectiveness and strategies for delivery in West Africa. Toxicon. 2013 Jul;69:82-9. doi: 10.1016/j.toxicon.2013.01.002. Epub 2013 Jan 20.

  PMID: 23339853 BACKGROUND

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Khadillar

  Premuim serums

  STUDY DIRECTOR

Central Study Contacts

Tatiana Djikeussi

CONTACT

+237655190562; chokokamfile@gmail.com

Lorraine Guedem

CONTACT

+237693374545; neklorraine2@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 27, 2024
• Study Start: August 26, 2024
• Primary Completion: February 26, 2025
• Study Completion: April 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CA (1)