Evaluation of Anti-venoms Serum in Africa

NCT03326492 | Completed

• 1 other identifier: 2016-092
• Study Type: observational
• Target: 474
• Locations: 1 country
• Sites: 13

Brief Summary

There is little or no assessment under real-use conditions of the efficacy and the tolerance in the short, medium and long term of the antivenoms currently on the market and used in the treatment of snake bites. The main objective is to assess the short term tolerance (\< 2 hours post-injection) of the antivenom Inoserp Pan-Africa® (temporary market authorization) from Inosan laboratory currently available in Cameroon.

Conditions

Snake Bites; Antivenins; Snake Venoms

Keywords

Snake bites; Antivenom serum; Snake venoms

Outcome Measures

Primary Outcomes (1)

• Short term tolerance of the antivenom serum Inoserp Pan-Africa®

  The short-term tolerance of the antivenom serum Inoserp Pan-Africa® will be assessed by the monitoring of the clinical signs occurence less than 2 hours post-injection

  30 months

Secondary Outcomes (3)

• Short term efficacy of the antivenom serum Inoserp Pan-Africa®

  30 months

• Medium term tolerance of the antivenom serum Inoserp Pan-Africa®

  30 months

• Medium term efficacy of the antivenom serum Inoserp Pan-Africa®

  30 months

Study Arms (1)

Patients bitten by a snake

Any patient over 5 years old going to a participating center for curative care following a snake bite. Participation to the study does not change usual follow-up of patients. Antivenom serum Inoserp Pan-Africa® injection will be decided according to the clinical evaluation of the patient.

Drug: Antivenom serum Inoserp Pan-Africa® injection

Interventions

Antivenom serum Inoserp Pan-Africa® injection DRUG

Participation to the study does not change usual follow-up of patients. All medical procedures will be performed and products will be used in a routine manner. Antivenom serum Inoserp Pan-Africa® injection will be decided according to the clinical evaluation of the patient.

Patients bitten by a snake

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient over 5 years old (inclusive) visiting at a participating center for curative care following a snake bite, with or without confirmed envenoming, will be proposed to participate in the study

You may qualify if:

• Any patient over 5 years old (inclusive) visiting at a participating center for a snake bite with or without confirmed envenoming
• Informed consent to research

You may not qualify if:

• Patient refusal
• Under 5 year-old
• Antivenom serum administration before the arrival in the participating center
• History of severe allergic reactions to antivenom serum

Sponsors & Collaborators

• Institut Pasteur: lead
• Cameroon Society of Epidemiology (CaSE): collaborator
• Centre International de Recherches d'Enseignements et de Soins (CIRES): collaborator
• Centre Pasteur du Cameroun: collaborator
• Inosan Biopharma: collaborator

Study Sites (13)

Hôpital de District d'Akonolinga

Akonolinga, Cameroon

Location

Hôpital régional de Buea

Buea, Cameroon

Location

Hôpital de District de Guider

Guider, Cameroon

Location

Hôpital de District de Kolofata

Kolofata, Cameroon

Location

Hôpital Régional de Limbe

Limbe, Cameroon

Location

Hôpital de District de Mora

Mora, Cameroon

Location

Hôpital Norvégien de N'Gaoundéré

N'Gaoundéré, Cameroon

Location

Hôpital Régional de N'Gaoundéré

N'Gaoundéré, Cameroon

Location

Hôpital Saint Malte de Njombe

Njombé, Cameroon

Location

Hôpital de District de Poli

Poli, Cameroon

Location

Hôpital de District de Sa'a

Sa'a, Cameroon

Location

Hôpital de District de Tokombere

Tokonbéré, Cameroon

Location

Centre des Urgences de Yaounde (CURY)

Yaoundé, Cameroon

Location

Related Publications (3)

• Chippaux JP, Amta P, Madec Y, Ntone R, Noel G, Clauteaux P, Boum Ii Y, Nkwescheu AS, Taieb F. Epidemiologic, clinical, and therapeutic aspects of formally identified Echis romani bites in northern Cameroon. PLoS Negl Trop Dis. 2025 Jul 28;19(7):e0013195. doi: 10.1371/journal.pntd.0013195. eCollection 2025 Jul.

  PMID: 40720423 BACKGROUND

• Benhammou D, Chippaux JP, Ntone R, Madec Y, Amta P, Noel G, Karl FN, Perilhou A, Matchim L, Sanchez M, Ndifon M, Clauteaux P, Eteki L, Boum Y 2nd, Nkwescheu AS, Taieb F. Snakebites in Cameroon: Tolerance of a Snake Antivenom (Inoserp PAN-AFRICA) in Africa in Real-Life Conditions. Toxins (Basel). 2024 Mar 22;16(4):165. doi: 10.3390/toxins16040165.

  PMID: 38668590 RESULT

• Chippaux JP, Ntone R, Benhammou D, Madec Y, Noel G, Perilhou A, Karl F, Amta P, Sanchez M, Matchim L, Clauteaux P, Eteki L, Ndifon M, Boum Y, Nkwescheu AS, Taieb F. Real life condition evaluation of Inoserp PAN-AFRICA antivenom effectiveness in Cameroon. PLoS Negl Trop Dis. 2023 Nov 8;17(11):e0011707. doi: 10.1371/journal.pntd.0011707. eCollection 2023 Nov.

  PMID: 37939111 RESULT

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

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

Study Officials

• Armand Nkwescheu, MD

  Cameroon Society of Epidemiology, Cameroon

  PRINCIPAL INVESTIGATOR

• Yap Boum, MD

  Médecins Sans Frontière

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: October 31, 2017
• Study Start: October 17, 2019
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: September 22, 2025

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)