Actively Recruiting

All Genders
Healthy Volunteers
ID06615960

Safety and Effectiveness of PANAF-Premium TM Snake Venom Antiserum as Standard Treatment for Snakebites in Cameroon - Phase IV Open Label Trial

Led by Premium Serums & Vaccines Pvt.Ltd. · Updated on 2024-09-27

112

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

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 patient’s 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.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of any age and sex with a history of snakebites or unknown bites at study sites
  • Willingness to participate by signing an informed consent form
  • Presence of one or more clinical signs of envenomation confirmed by examination or positive clot test
  • Signs of local envenomation such as bite marks, swelling, blistering, or skin color changes
  • Signs of systemic envenomation including neurotoxic or hemotoxic symptoms like paralysis, bleeding, or shock
  • Clinical condition severe enough to require antivenom administration
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Unable to understand the study's nature and consequences
  • Pre-existing serious health conditions such as renal disease, heart failure, or chronic lung disease
  • Use of medications like diuretics, anticoagulants, or antiplatelet drugs that may affect results
  • Known allergy to the investigational drug or similar substances
  • Participation in another investigational drug trial within 30 days prior
  • Physical or psychiatric conditions posing risk or interfering with study participation
  • Known or persistent abuse of drugs, medications, or alcohol
  • Clinically significant neurological, cardiac, pulmonary, hepatic, or renal disease assessed by history or examination
  • Pregnancy is not an exclusion in this study as previously sensitized or treated patients are included

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of hospital stay until clinical recovery

Participants who have been bitten by snakes and require treatment receive the PANAF-Premium TM Snake Venom Antiserum as per standard hospital protocol.

1 or more visits during hospital admission depending on clinical needs

Follow-up

Duration - Up to 30 days after treatment

Participants are monitored for safety and effectiveness outcomes, including any adverse reactions and recovery progress following treatment.

Multiple visits as needed up to 30 days post-treatment

Long-term Monitoring

Duration - Up to 6 months

Participants may be observed for epidemiological data collection regarding snake species and bite patterns in the region.

Visits or contacts as needed for data collection

Trial Site Locations

Total: 1 location

1

Garoua Regional Hospital

Garoua, North Region, Cameroon

Actively Recruiting

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Research Team

T

Tatiana Djikeussi

L

Lorraine Guedem

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Julien Potet, James Smith, Lachlan McIver

https://pubmed.ncbi.nlm.nih.gov/31233536