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Evaluation of Anti-venoms Serum in Africa (ESAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326492
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Cameroon Society of Epidemiology (CaSE)
Centre International de Recherches d'Enseignements et de Soins (CIRES)
Centre Pasteur du Cameroun
Inosan Biopharma
Information provided by (Responsible Party):
Institut Pasteur

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.


Condition or disease Intervention/treatment
Snake Bites Antivenins Snake Venoms Drug: Antivenom serum Inoserp Pan-Africa® injection

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Study Type : Observational
Estimated Enrollment : 470 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Anti-venoms Serum in Africa (ESAA). Data Collection in Real Life Conditions
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Short term tolerance of the antivenom serum Inoserp Pan-Africa® [ Time Frame: 30 months ]
    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


Secondary Outcome Measures :
  1. Short term efficacy of the antivenom serum Inoserp Pan-Africa® [ Time Frame: 30 months ]
    The short-term efficacy of the antivenom serum Inoserp Pan-Africa® will be assessed by the clinical evaluation when the patient arrives at the hospital and then regularly until 48 hours post-injection

  2. Medium term tolerance of the antivenom serum Inoserp Pan-Africa® [ Time Frame: 30 months ]
    The medium term tolerance of the antivenom serum Inoserp Pan-Africa® will be assessed by the monitoring of the clinical signs occurence more than 72 hours post-injection

  3. Medium term efficacy of the antivenom serum Inoserp Pan-Africa® [ Time Frame: 30 months ]
    The medium term efficacy of the antivenom serum Inoserp Pan-Africa® will be assessed by the vital status at 15 days of any patient who received at least one dose of the antivenom serum and by the reported consequences 15 days after the first dose administration of the antivenom serum



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326492


Contacts
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Contact: Fabien Taïeb, MD 1 44 38 93 10 ext +33 fabien.taieb@pasteur.fr
Contact: Yoann Madec 1 40 61 38 28 ext +33 yoann.madec@pasteur.fr

Locations
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Cameroon
Hôpital de District d'Akonolinga Recruiting
Akonolinga, Cameroon
Contact: Marcelline L. NGAH MVOGO, MD    676 92 32 23    larissamvogo@gmail.com   
Contact: Celestine AKAMBA    696 77 63 60      
Hôpital de District de Kolofata Recruiting
Kolofata, Cameroon
Contact: Kouli Guidang    695 22 37 44    kouliguidang@yahoo.fr   
Hôpital de District de Mora Recruiting
Mora, Cameroon
Contact: Mohaman DAIROU, MD    699 79 34 44    daldavamohaman@gmail.com   
Hôpital de District de Sa'a Recruiting
Sa'a, Cameroon
Contact: Malika Noumbissi BEMO, MD    696 42 49 67    bemomalika@yahoo.fr   
Hôpital de District de Tokombéré Recruiting
Tokombéré, Cameroon
Contact: Pierre Amta, MD    237 74928040      
Centre des Urgences de Yaounde (CURY) Recruiting
Yaoundé, Cameroon
Contact: Bernard MBARGA METOGO, MD    699 55 35 22    bernardmetogo@yahoo.fr   
Sponsors and Collaborators
Institut Pasteur
Cameroon Society of Epidemiology (CaSE)
Centre International de Recherches d'Enseignements et de Soins (CIRES)
Centre Pasteur du Cameroun
Inosan Biopharma
Investigators
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Principal Investigator: Armand Nkwescheu, MD Cameroon Society of Epidemiology, Cameroon
Principal Investigator: Yap Boum, MD Médecins Sans Frontière
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03326492    
Other Study ID Numbers: 2016-092
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Snake bites
Antivenom serum
Snake venoms
Additional relevant MeSH terms:
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Snake Bites
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Antivenins
Immunologic Factors
Physiological Effects of Drugs