SEPSIS project: a protocol for studying biomarkers of neonatal sepsis and immune responses of infants in a malaria-endemic region.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
23 07 2020
Historique:
entrez: 26 7 2020
pubmed: 28 7 2020
medline: 15 5 2021
Statut: epublish

Résumé

Neonatal sepsis outreaches all causes of neonatal mortality worldwide and remains a major societal burden in low and middle income countries. In addition to limited resources, endemic morbidities, such as malaria and prematurity, predispose neonates and infants to invasive infection by altering neonatal immune response to pathogens. Nevertheless, thoughtful epidemiological, diagnostic and immunological evaluation of neonatal sepsis and the impact of gestational malaria have never been performed. A prospective longitudinal multicentre follow-up of 580 infants from birth to 3 months of age in urban and suburban Benin will be performed. At delivery, and every other week, all children will be examined and clinically evaluated for occurrence of sepsis. At delivery, cord blood systematic analysis of selected plasma and transcriptomic biomarkers (procalcitonin, interleukin (IL)-6, IL-10, IP10, Ethical approval has been obtained from the Comité d'Ethique de la Recherche - Institut des Sciences Biomédicales Appliquées (CER-ISBA 85 - 5 April 2016, extended on 3 February 2017). Results will be disseminated through international presentations at scientific meetings and publications in peer-reviewed journals. ClinicalTrials.gov registration number: NCT03780712.

Identifiants

pubmed: 32709653
pii: bmjopen-2020-036905
doi: 10.1136/bmjopen-2020-036905
pmc: PMC7380952
doi:

Substances chimiques

Biomarkers 0

Banques de données

ClinicalTrials.gov
['NCT03780712']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e036905

Investigateurs

Aurax Fernando (A)
Urbain Ahouayito (U)
Basile Agossou (B)
Caleb Ezinmegnon (C)
Anauel Fortunato (A)
Josué Fiagbenou (J)
Djamirou Dossa (D)
Dramane Abdou (D)
Canisius Fantodji (C)
Nawal Sare (N)
Wilisto Bara (W)
Razack Monde (R)
Erasme Gbagidi (E)
Larissa Allokpe (L)
Armand Housemenou (A)
Landry Assongba (L)
Manfred Accrombessi (M)
Florent Kouhouenou (F)
Armand Hounsemenou (A)
Amour Ridagba (A)
Christiane Aguemon (C)
Dissou Affolabi (D)
Réné Perrin (R)
Benjamin Hounkpatin (B)
Dossou Dagba (D)
Luis Augusto (L)
Sophie Thibault (S)
François Bartolo (F)
Marine Mommert (M)
Karen Brengel-Pesce (K)

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: JYM, LV, JT, AP and SB are employed by an in vitro diagnostic company, bioMérieux SA. The remaining authors declare that this research was conducted in the absence of any commercial or financial relationship that could cause potential conflict of interest.

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Auteurs

Nadine Fievet (N)

Institut de Recherche pour le Développement (IRD), Mère et enfant face aux infections tropicales (UMR216), Paris, France.
COMUE Sorbonne Paris Cité, Universite Paris Descartes, Paris, Île-de-France, France.

Sem Ezinmegnon (S)

Department of Microbiology, Institut de Biologie Integrative de la Cellule, Gif-sur-Yvette, France.
Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l'Etoile, Rhône-Alpes, France.

Gino Agbota (G)

UMR216-MERIT, French National Research Institute for Sustainable Development (IRD), Université Paris Descartes, Paris, France.
Institut de Recherche Clinique du Bénin, Calavi, Benin.

Darius Sossou (D)

Institut de Recherche Clinique du Bénin, Calavi, Benin.

Rodolphe Ladekpo (R)

Institut de Recherche Clinique du Bénin, Calavi, Benin.

Komi Gbedande (K)

Institut de Recherche Clinique du Benin, Cotonou, Benin.

Valerie Briand (V)

Institut de Recherche pour le Développement (IRD), Mère et enfant face aux infections tropicales (UMR216), Paris, France.

Gilles Cottrell (G)

UMR216, Institut de Recherche pour le Développement, Cotonou, Benin.
Faculté de Pharmacie, Université Paris Descartes, Paris, France.

Laurence Vachot (L)

Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l'Etoile, Rhône-Alpes, France.

Javier Yugueros Marcos (J)

Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l'Etoile, Rhône-Alpes, France.

Alexandre Pachot (A)

EA 7426 Pathophysiology of Injury-Induced Immunosuppression, bioMerieux, LYON cedex 03, France.

Julien Textoris (J)

EA 7426 Pathophysiology of Injury-Induced Immunosuppression, bioMerieux, LYON cedex 03, France.
Département d'Anesthésie et de Réanimation, Hospices Civils de Lyon, LYON Cedex 03, France.

Sophie Blein (S)

Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l'Etoile, Rhône-Alpes, France.
EA 7426 Pathophysiology of Injury-Induced Immunosuppression, bioMerieux, LYON cedex 03, France.

Ulrik Lausten-Thomsen (U)

Pediatric Intensive Care, Hopitaux Universitaires Paris-Sud, Le Kremlin-Bicetre, France.

Achille Massougbodji (A)

Faculté des Sciences de la Santé (FSS), Cotonou, Benin.

Lehila Bagnan (L)

Institut de Recherche Clinique du Bénin, Calavi, Benin.
Department of Paediatric, National University Hospital Center (CNHU), Cotonou, Benin.

Nicole Tchiakpe (N)

Institut de Recherche Clinique du Bénin, Calavi, Benin.
Department of Paediatric, Centre Hospitalier Universitaire de la Mère et de l'Enfant Lagune (CHUMEL), Cotonou, Benin.

Marceline d'Almeida (M)

Department of Paediatric, National University Hospital Center (CNHU), Cotonou, Benin.
Institut de Recherche Clinique du Benin, Calavi, Île-de-France, Benin.

Jules Alao (J)

CHU-MEL Hospital, Cotonou, Benin.

Ida Dossou-Dagba (I)

Calavi Hospital, Calavi, Benin.

Pierre Tissieres (P)

Department of Microbiology, Institut de Biologie Integrative de la Cellule, Gif-sur-Yvette, France pierre.tissieres@aphp.fr.
Pediatric Intensive Care, Hopitaux Universitaires Paris-Sud, Le Kremlin-Bicetre, France.

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