Safety and Effectiveness of PANAF-Premium Snake Venom Antiserum for Treating Snakebites in Cameroon Phase IV Open Label Post-Marketing Study

What this Trial Is About

Snakebite envenomation is a serious health issue in many developing countries, including sub-Saharan Africa. This research evaluates the safety and effectiveness of PANAF-Premium TM, a snake venom antiserum recently introduced by Premium Serums & Vaccines Pvt. Ltd. and approved by the WHO for use in sub-Saharan Africa. The study focuses on collecting detailed safety, effectiveness, and epidemiological data related to snakebites in the North region of Cameroon, contributing to broader pharmacovigilance efforts. The study is an open-label, Phase IV post-marketing surveillance trial where eligible patients with snakebites are treated with PANAF-Premium TM according to standard protocols adapted from the African Society of Venomology guidelines. The trial documents adverse events, the dose of antiserum required, and recovery time. There are no restrictions on other treatments or medications given as needed to manage the patients condition. Participants admitted with snakebites will undergo clinical examinations to identify signs of envenomation. Researchers will record adverse reactions, snake species involved, and the treatment process. Safety and effectiveness outcomes are monitored for 30 days, while epidemiological data are collected over six months. The study aims to enhance understanding of snakebite treatment and safety, with ongoing reporting of any serious adverse events.

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