Status:
COMPLETED
Evaluation and Support to EVD Cured Patients and Their Contacts (Les Vainqueurs d'Ebola)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Institut de Recherche pour le Developpement
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
5+ years
Brief Summary
Ebola virus is one of the most dangerous human pathogens and is an emerging public health problem in sub-Saharan Africa. Ebola virus disease (EVD) first appeared in 1976. The current epidemic in the D...
Eligibility Criteria
Inclusion
- In cured population
- Age ≥ 5 years
- Adults and children after an acute episode declared cured of biologically confirmed Ebola virus disease (two negative PCRs are required at least 24 hours apart so that a patient without clinical symptoms can leave the Ebola treatment center),
- Informed consent signed by at least one of the two parents or the legal guardian authorizing the child's participation in the study,
- Volunteer participant who signed the informed consent for adults.
- In CONTACT population
- Age ≥ 5 years,
- Be a contact person of a cured patient (ie patient with a proven EVD, and with two negative PCRs at least 24 hours apart) included in the cohort of Ebola Winners. Based on WHO recommendations and the Centers for Disease Control and Prevention for the identification and traceability of contact subjects: a contact person is defined as a person who encountered the index case during his EVD in his residence, ie having the same place of life as him,
- Have not been diagnosed with EVD,
- Participation agreement:
- For adult participants (≥ 18 years old, emancipated or married): informed consent intended for the adult participant signed,
- For minors ≥ 5 years old: informed consent intended for the parent(s)/legal guardian signed by at least one of the two parents or the legal guardian and assent form intended for the minor participant completed.
- In cellular immunological sub-study:
- Adult participants in the parent study ≥ 18 years old,
- Accept to participate in this sub-study
- Negative blood EBOV PCR
Exclusion
- Absence of possible follow-up over 12 months from a logistical or geographical point of view (only for cured patients);
- Non-residents in the DRC;
- Impossibility of complying with the requirements and procedures of the study in the opinion of the investigator;
- Inability to consent.
Key Trial Info
Start Date :
April 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
787 Patients enrolled
Trial Details
Trial ID
NCT04409405
Start Date
April 16 2020
End Date
October 18 2021
Last Update
October 1 2025
Active Locations (4)
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1
Beni Hospital
Beni, Democratic Republic of the Congo
2
Mangina Hospital
Beni, Democratic Republic of the Congo
3
Butembo Hospital
Butembo, Democratic Republic of the Congo
4
Mambasa Hospital
Mambasa, Democratic Republic of the Congo