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dc.contributor.authorPavlinac, Patricia B
dc.contributor.authorPlatts-Mills, James A
dc.contributor.authorTickell, Kirkby D
dc.contributor.authorLiu, Jie
dc.contributor.authorJuma, Jane
dc.contributor.authorKabir, Furqan
dc.contributor.authorNkeze, Joseph
dc.contributor.authorOkoi, Catherine
dc.contributor.authorOperario, Darwin J
dc.contributor.authorUddin, Jashim
dc.contributor.authorAhmed, Shahnawaz
dc.contributor.authorAlonso, Pedro L
dc.contributor.authorAntonio, Martin
dc.contributor.authorBecker, Stephen M
dc.contributor.authorBreiman, Robert F
dc.contributor.authorFaruque, Abu S G
dc.contributor.authorFields, Barry
dc.contributor.authorGratz, Jean
dc.contributor.authorHaque, Rashidul
dc.contributor.authorHossain, Anowar
dc.contributor.authorHossain, M Jahangir
dc.contributor.authorJarju, Sheikh
dc.contributor.authorQamar, Farah
dc.contributor.authorIqbal, Najeeha Talat
dc.contributor.authorKwambana, Brenda
dc.contributor.authorMandomando, Inacio
dc.contributor.authorMcMurry, Timothy L
dc.contributor.authorOchieng, Caroline
dc.contributor.authorOchieng, John B
dc.contributor.authorOchieng, Melvin
dc.contributor.authorOnyango, Clayton
dc.contributor.authorPanchalingam, Sandra
dc.contributor.authorKalam, Adil
dc.contributor.authorAziz, Fatima
dc.contributor.authorQureshi, Shahida
dc.contributor.authorRamamurthy, Thandavarayan
dc.contributor.authorRoberts, James H
dc.contributor.authorSaha, Debasish
dc.contributor.authorSow, Samba O
dc.contributor.authorStroup, Suzanne E
dc.contributor.authorSur, Dipika
dc.contributor.authorTamboura, Boubou
dc.contributor.authorTaniuchi, Mami
dc.contributor.authorTennant, Sharon M
dc.contributor.authorRoose, Anna
dc.contributor.authorToema, Deanna
dc.contributor.authorWu, Yukun
dc.contributor.authorZaidi, Anita
dc.contributor.authorNataro, James P
dc.contributor.authorLevine, Myron M
dc.contributor.authorHoupt, Eric R
dc.contributor.authorKotloff, Karen L
dc.date.accessioned2021-09-14T16:08:38Z
dc.date.available2021-09-14T16:08:38Z
dc.date.issued2020-10-12en_US
dc.identifier.urihttp://hdl.handle.net/10713/16650
dc.description.abstractBACKGROUND: Shigella is a leading cause of childhood diarrhea and target for vaccine development. Microbiologic and clinical case definitions are needed for pediatric field vaccine efficacy trials. METHODS: We compared characteristics of moderate to severe diarrhea (MSD) cases in the Global Enteric Multicenter Study (GEMS) between children with culture positive Shigella to those with culture-negative, quantitative polymerase chain reaction (qPCR)-attributable Shigella (defined by an ipaH gene cycle threshold <27.9). Among Shigella MSD cases, we determined risk factors for death and derived a clinical severity score. RESULTS: Compared to culture-positive Shigella MSD cases (n = 745), culture-negative/qPCR-attributable Shigella cases (n = 852) were more likely to be under 12 months, stunted, have a longer duration of diarrhea, and less likely to have high stool frequency or a fever. There was no difference in dehydration, hospitalization, or severe classification from a modified Vesikari score. Twenty-two (1.8%) Shigella MSD cases died within the 14-days after presentation to health facilities, and 59.1% of these deaths were in culture-negative cases. Age <12 months, diarrhea duration prior to presentation, vomiting, stunting, wasting, and hospitalization were associated with mortality. A model-derived score assigned points for dehydration, hospital admission, and longer diarrhea duration but was not significantly better at predicting 14-day mortality than a modified Vesikari score. CONCLUSIONS: A composite severity score consistent with severe disease or dysentery may be a pragmatic clinical endpoint for severe shigellosis in vaccine trials. Reliance on culture for microbiologic confirmation may miss a substantial number of Shigella cases but is currently required to measure serotype specific immunity. © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.en_US
dc.description.urihttps://doi.org/10.1093/cid/ciaa1545en_US
dc.language.isoenen_US
dc.publisherOxford University Pressen_US
dc.relation.ispartofClinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of Americaen_US
dc.rights© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.en_US
dc.subjectpolymerase chain reactionen_US
dc.subjectdehydrationen_US
dc.subjectdiarrheaen_US
dc.subjectdysenteryen_US
dc.subjectchilden_US
dc.subjectpediatricsen_US
dc.subjectvomitingen_US
dc.subjectshigella infectionsen_US
dc.subjectshigellaen_US
dc.subjectvaccine clinical trialen_US
dc.titleThe Clinical Presentation of Culture-positive and Culture-negative, Quantitative Polymerase Chain Reaction (qPCR)-Attributable Shigellosis in the Global Enteric Multicenter Study and Derivation of a Shigella Severity Score: Implications for Pediatric Shigella Vaccine Trialsen_US
dc.typeArticleen_US
dc.identifier.doi10.1093/cid/ciaa1545
dc.identifier.pmid33044509
dc.source.volume73
dc.source.issue3
dc.source.beginpagee569
dc.source.endpagee579
dc.source.countryUnited States


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