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The 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 Trials

BACKGROUND: 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...

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Autores principales: Pavlinac, Patricia B, Platts-Mills, James A, Tickell, Kirkby D, Liu, Jie, Juma, Jane, Kabir, Furqan, Nkeze, Joseph, Okoi, Catherine, Operario, Darwin J, Uddin, Jashim, Ahmed, Shahnawaz, Alonso, Pedro L, Antonio, Martin, Becker, Stephen M, Breiman, Robert F, Faruque, Abu S G, Fields, Barry, Gratz, Jean, Haque, Rashidul, Hossain, Anowar, Hossain, M Jahangir, Jarju, Sheikh, Qamar, Farah, Iqbal, Najeeha Talat, Kwambana, Brenda, Mandomando, Inacio, McMurry, Timothy L, Ochieng, Caroline, Ochieng, John B, Ochieng, Melvin, Onyango, Clayton, Panchalingam, Sandra, Kalam, Adil, Aziz, Fatima, Qureshi, Shahida, Ramamurthy, Thandavarayan, Roberts, James H, Saha, Debasish, Sow, Samba O, Stroup, Suzanne E, Sur, Dipika, Tamboura, Boubou, Taniuchi, Mami, Tennant, Sharon M, Roose, Anna, Toema, Deanna, Wu, Yukun, Zaidi, Anita, Nataro, James P, Levine, Myron M, Houpt, Eric R, Kotloff, Karen L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8326551/
https://www.ncbi.nlm.nih.gov/pubmed/33044509
http://dx.doi.org/10.1093/cid/ciaa1545
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author Pavlinac, Patricia B
Platts-Mills, James A
Tickell, Kirkby D
Liu, Jie
Juma, Jane
Kabir, Furqan
Nkeze, Joseph
Okoi, Catherine
Operario, Darwin J
Uddin, Jashim
Ahmed, Shahnawaz
Alonso, Pedro L
Antonio, Martin
Becker, Stephen M
Breiman, Robert F
Faruque, Abu S G
Fields, Barry
Gratz, Jean
Haque, Rashidul
Hossain, Anowar
Hossain, M Jahangir
Jarju, Sheikh
Qamar, Farah
Iqbal, Najeeha Talat
Kwambana, Brenda
Mandomando, Inacio
McMurry, Timothy L
Ochieng, Caroline
Ochieng, John B
Ochieng, Melvin
Onyango, Clayton
Panchalingam, Sandra
Kalam, Adil
Aziz, Fatima
Qureshi, Shahida
Ramamurthy, Thandavarayan
Roberts, James H
Saha, Debasish
Sow, Samba O
Stroup, Suzanne E
Sur, Dipika
Tamboura, Boubou
Taniuchi, Mami
Tennant, Sharon M
Roose, Anna
Toema, Deanna
Wu, Yukun
Zaidi, Anita
Nataro, James P
Levine, Myron M
Houpt, Eric R
Kotloff, Karen L
author_facet Pavlinac, Patricia B
Platts-Mills, James A
Tickell, Kirkby D
Liu, Jie
Juma, Jane
Kabir, Furqan
Nkeze, Joseph
Okoi, Catherine
Operario, Darwin J
Uddin, Jashim
Ahmed, Shahnawaz
Alonso, Pedro L
Antonio, Martin
Becker, Stephen M
Breiman, Robert F
Faruque, Abu S G
Fields, Barry
Gratz, Jean
Haque, Rashidul
Hossain, Anowar
Hossain, M Jahangir
Jarju, Sheikh
Qamar, Farah
Iqbal, Najeeha Talat
Kwambana, Brenda
Mandomando, Inacio
McMurry, Timothy L
Ochieng, Caroline
Ochieng, John B
Ochieng, Melvin
Onyango, Clayton
Panchalingam, Sandra
Kalam, Adil
Aziz, Fatima
Qureshi, Shahida
Ramamurthy, Thandavarayan
Roberts, James H
Saha, Debasish
Sow, Samba O
Stroup, Suzanne E
Sur, Dipika
Tamboura, Boubou
Taniuchi, Mami
Tennant, Sharon M
Roose, Anna
Toema, Deanna
Wu, Yukun
Zaidi, Anita
Nataro, James P
Levine, Myron M
Houpt, Eric R
Kotloff, Karen L
author_sort Pavlinac, Patricia B
collection PubMed
description BACKGROUND: 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.
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spelling pubmed-83265512021-08-02 The 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 Trials Pavlinac, Patricia B Platts-Mills, James A Tickell, Kirkby D Liu, Jie Juma, Jane Kabir, Furqan Nkeze, Joseph Okoi, Catherine Operario, Darwin J Uddin, Jashim Ahmed, Shahnawaz Alonso, Pedro L Antonio, Martin Becker, Stephen M Breiman, Robert F Faruque, Abu S G Fields, Barry Gratz, Jean Haque, Rashidul Hossain, Anowar Hossain, M Jahangir Jarju, Sheikh Qamar, Farah Iqbal, Najeeha Talat Kwambana, Brenda Mandomando, Inacio McMurry, Timothy L Ochieng, Caroline Ochieng, John B Ochieng, Melvin Onyango, Clayton Panchalingam, Sandra Kalam, Adil Aziz, Fatima Qureshi, Shahida Ramamurthy, Thandavarayan Roberts, James H Saha, Debasish Sow, Samba O Stroup, Suzanne E Sur, Dipika Tamboura, Boubou Taniuchi, Mami Tennant, Sharon M Roose, Anna Toema, Deanna Wu, Yukun Zaidi, Anita Nataro, James P Levine, Myron M Houpt, Eric R Kotloff, Karen L Clin Infect Dis Online Only Articles BACKGROUND: 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. Oxford University Press 2020-10-12 /pmc/articles/PMC8326551/ /pubmed/33044509 http://dx.doi.org/10.1093/cid/ciaa1545 Text en © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Online Only Articles
Pavlinac, Patricia B
Platts-Mills, James A
Tickell, Kirkby D
Liu, Jie
Juma, Jane
Kabir, Furqan
Nkeze, Joseph
Okoi, Catherine
Operario, Darwin J
Uddin, Jashim
Ahmed, Shahnawaz
Alonso, Pedro L
Antonio, Martin
Becker, Stephen M
Breiman, Robert F
Faruque, Abu S G
Fields, Barry
Gratz, Jean
Haque, Rashidul
Hossain, Anowar
Hossain, M Jahangir
Jarju, Sheikh
Qamar, Farah
Iqbal, Najeeha Talat
Kwambana, Brenda
Mandomando, Inacio
McMurry, Timothy L
Ochieng, Caroline
Ochieng, John B
Ochieng, Melvin
Onyango, Clayton
Panchalingam, Sandra
Kalam, Adil
Aziz, Fatima
Qureshi, Shahida
Ramamurthy, Thandavarayan
Roberts, James H
Saha, Debasish
Sow, Samba O
Stroup, Suzanne E
Sur, Dipika
Tamboura, Boubou
Taniuchi, Mami
Tennant, Sharon M
Roose, Anna
Toema, Deanna
Wu, Yukun
Zaidi, Anita
Nataro, James P
Levine, Myron M
Houpt, Eric R
Kotloff, Karen L
The 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 Trials
title The 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 Trials
title_full The 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 Trials
title_fullStr The 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 Trials
title_full_unstemmed The 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 Trials
title_short The 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 Trials
title_sort 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 trials
topic Online Only Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8326551/
https://www.ncbi.nlm.nih.gov/pubmed/33044509
http://dx.doi.org/10.1093/cid/ciaa1545
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AT antoniomartin clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT beckerstephenm clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT breimanrobertf clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT faruqueabusg clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT fieldsbarry clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT gratzjean clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT haquerashidul clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT hossainanowar clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT hossainmjahangir clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT jarjusheikh clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT qamarfarah clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT iqbalnajeehatalat clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT kwambanabrenda clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT mandomandoinacio clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT mcmurrytimothyl clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT ochiengcaroline clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT ochiengjohnb clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT ochiengmelvin clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT onyangoclayton clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT panchalingamsandra clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT kalamadil clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT azizfatima clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT qureshishahida clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT ramamurthythandavarayan clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT robertsjamesh clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT sahadebasish clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT sowsambao clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT stroupsuzannee clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT surdipika clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT tambouraboubou clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT taniuchimami clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT tennantsharonm clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT rooseanna clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT toemadeanna clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT wuyukun clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT zaidianita clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT natarojamesp clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT levinemyronm clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT houptericr clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials
AT kotloffkarenl clinicalpresentationofculturepositiveandculturenegativequantitativepolymerasechainreactionqpcrattributableshigellosisintheglobalentericmulticenterstudyandderivationofashigellaseverityscoreimplicationsforpediatricshigellavaccinetrials