Prediction of disease severity in young children presenting with acute febrile illness in resource-limited settings: a protocol for a prospective observational study.
infectious diseases
paediatrics
primary care
public health
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
25 01 2021
25 01 2021
Historique:
entrez:
26
1
2021
pubmed:
27
1
2021
medline:
15
5
2021
Statut:
epublish
Résumé
In rural and difficult-to-access settings, early and accurate recognition of febrile children at risk of progressing to serious illness could contribute to improved patient outcomes and better resource allocation. This study aims to develop a prognostic clinical prediction tool to assist community healthcare providers identify febrile children who might benefit from referral or admission for facility-based medical care. This prospective observational study will recruit at least 4900 paediatric inpatients and outpatients under the age of 5 years presenting with an acute febrile illness to seven hospitals in six countries across Asia. A venous blood sample and nasopharyngeal swab is collected from each participant and detailed clinical data recorded at presentation, and each day for the first 48 hours of admission for inpatients. Multianalyte assays are performed at reference laboratories to measure a panel of host biomarkers, as well as targeted aetiological investigations for common bacterial and viral pathogens. Clinical outcome is ascertained on day 2 and day 28.Presenting syndromes, clinical outcomes and aetiology of acute febrile illness will be described and compared across sites. Following the latest guidance in prediction model building, a prognostic clinical prediction model, combining simple clinical features and measurements of host biomarkers, will be derived and geographically externally validated. The performance of the model will be evaluated in specific presenting clinical syndromes and fever aetiologies. The study has received approval from all relevant international, national and institutional ethics committees. Written informed consent is provided by the caretaker of all participants. Results will be shared with local and national stakeholders, and disseminated via peer-reviewed open-access journals and scientific meetings. NCT04285021.
Identifiants
pubmed: 33495264
pii: bmjopen-2020-045826
doi: 10.1136/bmjopen-2020-045826
pmc: PMC7839891
doi:
Banques de données
ClinicalTrials.gov
['NCT04285021']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e045826Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 219644/Z/19/Z
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Clin Infect Dis. 2020 Mar 17;70(7):1304-1312
pubmed: 31102510
PLoS Negl Trop Dis. 2016 Mar 16;10(3):e0004497
pubmed: 26982706
PLoS One. 2011 Mar 01;6(3):e17053
pubmed: 21390301
Trop Med Int Health. 2006 Jun;11(6):869-79
pubmed: 16772009
JAMA. 2007 May 23;297(20):2232-40
pubmed: 17519413
PLoS Med. 2012;9(5):1-12
pubmed: 22629234
Bull World Health Organ. 2006 Apr;84(4):314-9
pubmed: 16628305
Ann Intern Med. 2015 Jan 6;162(1):W1-73
pubmed: 25560730
Front Immunol. 2018 Apr 24;9:838
pubmed: 29740443
N Engl J Med. 2014 Feb 27;370(9):809-17
pubmed: 24571753
Stat Med. 2016 Jan 30;35(2):214-26
pubmed: 26553135
J Clin Epidemiol. 2019 Oct;114:38-48
pubmed: 31150837
J Clin Microbiol. 2018 May 25;56(6):
pubmed: 29593057
Malar J. 2018 Oct 10;17(1):353
pubmed: 30305137
J Infect Dis. 2000 Jul;182(1):363-6
pubmed: 10882626
PLoS One. 2011 Feb 25;6(2):e17440
pubmed: 21364762
Clin Microbiol Infect. 2018 Aug;24(8):845-855
pubmed: 29684634
BMJ. 2013 Apr 02;346:f1706
pubmed: 23550046
Jpn J Infect Dis. 2008 Jan;61(1):31-5
pubmed: 18219131
PLoS One. 2015 Jun 30;10(6):e0127962
pubmed: 26126200
BMC Med. 2018 Mar 9;16(1):37
pubmed: 29519240
Crit Care. 2004 Apr;8(2):R82-90
pubmed: 15025782
Am J Trop Med Hyg. 2015 Jul;93(1):178-80
pubmed: 25918207
BMC Pediatr. 2018 Mar 23;18(1):118
pubmed: 29571293
PLoS One. 2019 Jan 28;14(1):e0211274
pubmed: 30689660
BMC Pediatr. 2018 Mar 13;18(1):109
pubmed: 29534694
PLoS One. 2017 Apr 18;12(4):e0175130
pubmed: 28419100
PLoS One. 2016 May 17;11(5):e0155830
pubmed: 27187773
JAMA. 2016 Aug 23-30;316(8):835-45
pubmed: 27552617
Lancet Respir Med. 2018 Mar;6(3):223-230
pubmed: 29508706
J Thromb Haemost. 2015 Sep;13(9):1653-64
pubmed: 26186686
Braz J Infect Dis. 2010 May-Jun;14(3):252-5
pubmed: 20835508
Proc Natl Acad Sci U S A. 2008 Nov 4;105(44):17097-102
pubmed: 18957536
BMC Med. 2020 Jul 1;18(1):159
pubmed: 32605575
Proc Natl Acad Sci U S A. 2016 Mar 1;113(9):2472-7
pubmed: 26884170
PLoS One. 2013 Apr 09;8(4):e60634
pubmed: 23593267
Stat Med. 2019 Mar 30;38(7):1276-1296
pubmed: 30357870
BMJ. 2009 Mar 31;338:b604
pubmed: 19336487
BMC Pediatr. 2017 Jan 26;17(1):37
pubmed: 28122537
Emerg Infect Dis. 2018 Feb;24(2):311-319
pubmed: 29350145
Open Forum Infect Dis. 2016 Jun 20;3(3):ofw134
pubmed: 27703996
Crit Care. 2010;14(3):R91
pubmed: 20492647
Clin Microbiol Infect. 2018 Dec;24(12):1341.e1-1341.e7
pubmed: 29555393
PLoS One. 2009;4(3):e4912
pubmed: 19300530
BMJ. 2020 Mar 18;368:m441
pubmed: 32188600
Lancet Infect Dis. 2020 Feb;20(2):179-187
pubmed: 31843383
Clin Infect Dis. 2012 Apr;54(8):1080-90
pubmed: 22412067
Clin Infect Dis. 2011 Sep;53(6):548-54
pubmed: 21865191
PLoS One. 2019 May 22;14(5):e0217146
pubmed: 31116772
Lancet. 2020 Jan 18;395(10219):200-211
pubmed: 31954465
BMC Infect Dis. 2019 Sep 3;19(1):769
pubmed: 31481123
J Virol. 2007 Feb;81(4):1592-600
pubmed: 17151115
Circulation. 2005 Apr 5;111(13):1660-5
pubmed: 15795332
Crit Care. 2015 Feb 23;19:47
pubmed: 25879892
Am J Trop Med Hyg. 2013 Aug;89(2):232-237
pubmed: 23817332
Am J Trop Med Hyg. 2012 Nov;87(5 Suppl):6-10
pubmed: 23136272
Soc Sci Med. 2014 Mar;104:56-63
pubmed: 24581062
Arch Dis Child. 2002 Apr;86(4):282-5
pubmed: 11919107
BMC Med. 2015 Jul 31;13:174
pubmed: 26228245