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
RSV GOLD III—ICU Network study group
(2021) BMC Infectious Diseases, volume 21, issue 1
(Article)
Abstract
BACKGROUND: Respiratory 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.
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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. METHODS: The 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. DISCUSSION: This 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.
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Keywords: Awareness, Burden, Children, Lower-middle-income countries, Pediatric intensive care unit, Respiratory syncytial virus, Study design, Infectious Diseases
ISSN: 1471-2334
Publisher: BioMed Central
Note: Funding Information: This study is funded by the Bill & Melinda Gates Foundation. The funder reviewed the study protocol and provided feedback, but has no role in the study design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit the protocol or future results for publication. Funding Information: In addition, we thank the following study staff from participating study sites: Fatima Abdullahi, Hamdalla Adelaiye, Abiola Oloruookoba, Fadlulah Abdu-rahman, Halima Mudasir, Abdulrahman Zakariya, Nana Aisha Makarfi, Suleiman Bello (Ahmadu Bello University Teaching Hospital), Amie Conteh, Musa Jaiteh, Sheikh Joof, Momodou Lamin Jobarteh, Ansumana Badjie, Mariama A. Jallow, Abdoulie Garba (Edward Francis Small teaching Hospital), Dr. Safaa Medani (Alneelain University), Khalid Enan, Dina N Abdelrahman, Mohamed O Mustafa, Razan A Bashir, Tarteel Hassan, Hassan Madni, Mutaz A Elsir, Awadalkareem Y Awadalkareem, Musab D Hassan, Abdel Rahim M El Hussein (Virology Department Central Laboratory Sudan), Eugenia Macassa, Stella Langa, Afsha Tahibo, W. Chris Buck (Maputo Central Hospital), Jahit Sacarlal, Samuel Simbine, Alfeu Passanduca (Eduardo Mondlane University Medical School), Prakash Joshi (Kanti Children’s Hospital), Rupesh Shrestha (Tribhuvan University Teaching Hospital), Bekolo Cavin Epie, Agnes Eyoh (Laquintinie hospital Douala), Missael Jn Leger, Jean Peterson Noel Fils, Alexandra Deroncelay, Jamesley Joseph (Saint-Damien Hospital). We also thank Trisja Boom, Safia Laqqa, and Renate Visser for their contributions to setting up this study. Furthermore, we thank Prachi Vora and Padmini Srikantiah for their scientific advice. The RSV GOLD III—ICU Network study group authors are (listed in hospital alphabetical order): Ahmadu Bello University Teaching Hospital, Zaria, Nigeria (Maria Ahuoiza Garba, Fatima Jumai Giwa); Balkh regional hospital, Mazar-e-Sharif, Afghanistan (Mohammad Hafiz Rasooly, Aminullah Shirpoor, Merwais Azizyar); Edward Francis Small Teaching Hospital, Banjul, The Gambia (Lamin Makalo, Ousman Nyan); Jafar Ibn Auf Specialized Hospital for Children, Khartoum, Sudan (Ali Mohamed, Khalid Osman); Kanti Children’s Hospital, Kathmandu, Nepal (Ram Hari Chapagain, Krishna Prasad Bista); Tribhuvan University Teaching Hospital, Kathmandu, Nepal (Arun Kumar Sharma, Prabina Shrestha); Korle Bu Teaching Hospital, Accra, Ghana (Bamenla Goka, Kwabena Osman); Noguchi Memorial Institute for Medical Research (Evangeline Obodai); Laquintinie hospital, Douala, Cameroon (Henshaw Mandi, Lucas Esuh Esong, Charlotte Ekoube Eposse); Maputo Central Hospital, Maputo, Mozambique (Valéria Muando) and Eduardo Mondlane University Medical School (Tufária Mussá); Muhimbili National Hospital, Dar es Salaam, Tanzania (Yasser Habresh Said, Aika Abia Shoo); Saint-Damien Hospital, Port-au-Prince, Haiti (Vanessa Jaelle Dor, Jacqueline Gautier, Linda Abicher). Funding Information: LJB has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. UMCU has received major funding (> €100,000 per industrial partner) for investigator-initiated studies from AbbVie, MedImmune, Janssen, the Bill and Melinda Gates Foundation, Nutricia (Danone) and MeMed Diagnostics. UMCU has received major cash or in kind funding as part of the public private partnership IMI-funded RESCEU project from GSK, Novavax, Janssen, AstraZeneca, Pfizer and Sanofi. UMCU has received major funding by Julius Clinical for participating in the INFORM study sponsored by MedImmune. UMCU has received minor funding for participation in trials by Regeneron and Janssen from 2015 to 2017 (total annual estimate less than €20,000). UMCU received minor funding for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, Novavax, Pfizer, Janssen (total annual estimate less than €20,000). LJB is the founding chairman of the ReSViNET Foundation. NIM has regular interaction with pharmaceutical and other industrial partners. She has not received personal fees or other personal benefits. HN reports grants from Innovative Medicines Initiative and National Institute of Health Research; personal fees and grants from WHO and Sanofi; and personal fees from the Bill & Melinda Gates Foundation, Janssen, Abbvie, and Reviral.GvT is involved in public private partnerships (EU Innovative Medicines Initiative consortia). She has not received personal fees or other personal benefits. Publisher Copyright: © 2021, The Author(s).
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