Describing global pediatric RSV disease at intensive care units in GAVI-eligible countries using molecular point-of-care diagnostics: the RSV GOLD-III study protocol

Yvette N Löwensteyn ,Yasser Habresh Said,Ram Hari Chapagain,Valéria I Muando ,Mohammad Hafiz Rasooly ,Arun Kumar Sharma ,Kwabena Agyapong Osman ,Pramesh Sunder Shrestha ,Krishna Bista ,Ali Shamim Mohamed ,Aika Shoo ,Bamenla Goka ,Vanessa Jaelle Dor,Charlotte Eposse ,Harish Nair,Fatima Jumai Giwa,Tufária Mussá ,Ousman Nyan,Aminullah Shirpoor,Lamin Makalo,Joukje Willemsen ,Lucas Esuh Esong,Linda Abicher ,Ghislaine J M W Van Thiel ,Khalid Osman,Merwais Azizyar,Evangeline Obodai,Natalie I Mazur ,Henshaw Mandi,Louis Bont,Maria Ahuoiza Garba,Jacqueline Gautier,Null Author_Id

doi:10.1186/s12879-021-06544-3

Abstract

BackgroundRespiratory syncytial virus (RSV) infection is an important cause of hospitalization and death in young children. The majority of deaths (99%) occur in low- and lower-middle-income countries (LMICs). Vaccines against RSV infection are underway. To obtain access to RSV interventions, LMICs depend on support from Gavi, the Vaccine Alliance. To identify future vaccine target populations, information on children with severe RSV infection is required. However, there is a lack of individual patient-level clinical data on instances of life-threatening RSV infection in LMICs. The RSV GOLD III—ICU Network study aims to describe clinical, demographic and socioeconomic characteristics of children with life-threatening RSV infection in Gavi-eligible countries.MethodsThe RSV GOLD-III—ICU Network study is an international, prospective, observational multicenter study and will be conducted in 10 Gavi-eligible countries at pediatric intensive care units and high-dependency units (PICUs/HDUs) during local viral respiratory seasons for 2 years. Children younger than 2 years of age with respiratory symptoms fulfilling the World Health Organization (WHO) “extended severe acute respiratory infection (SARI)” case definition will be tested for RSV using a molecular point-of-care (POC) diagnostic device. Patient characteristics will be collected through a questionnaire. Mortality rates of children admitted to the PICU and/or HDU will be calculated.DiscussionThis multicenter descriptive study will provide a better understanding of the characteristics and mortality rates of children younger than 2 years with RSV infection admitted to the PICU/HDU in LMICs. These results will contribute to knowledge on global disease burden and awareness of RSV and will directly guide decision makers in their efforts to implement future RSV prevention strategies.Trial registration number: NL9519, May 27, 2021

Highlights

Respiratory syncytial virus (RSV) infection is an important cause of hospitalization and death in young children
This study aims to obtain individual patient-level data from children who have been admitted with severe RSV infection at the intensive care unit (ICU) or high-dependency unit (HDU) in Gavi-eligible countries through implementation of RSV point-of-care testing to pave the way for future vaccine introduction
The critical lack of diagnostic capacity hampers the ability to distinguish RSV from other causes of severe respiratory infection in children to justify the need for vaccine introduction in Low- and lower-middle income country (LMIC)

Summary

Introduction

Respiratory syncytial virus (RSV) infection is an important cause of hospitalization and death in young children. Respiratory syncytial virus (RSV) infection is an important cause of hospitalization and mortality due to lower respiratory tract infection (LRTI) in children under 5 years of age worldwide [1]. The majority of deaths (99%) occur in low- and lowermiddle-income countries (LMICs) due to lack of access to healthcare and poor quality of care in health facilities [1], and children under 2 years of age are disproportionally affected [2, 3]. A new extended half-life monoclonal antibody developed by SanofiPasteur / MedImmune, nirsevimab (previously MEDI8897), has met the primary endpoint of reducing RSV LRTI in healthy infants in a recent phase III trial [6]

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