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

NCT06615960 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2024-09-27

No results posted yet for this study

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

Sponsors & Collaborators

  • Premium Serums & Vaccines Pvt.Ltd.

    lead INDUSTRY

Principal Investigators

  • Khadillar · Premuim serums

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2025-02-26
Completion
2025-04-30

Countries

  • Cameroon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06615960 on ClinicalTrials.gov