Evidence map›Paper›PMID 33044509›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

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.

Patricia B Pavlinac, James A Platts-Mills, Kirkby D Tickell, Jie Liu, Jane Juma, Furqan Kabir, Joseph Nkeze, Catherine Okoi, Darwin J Operario, Jashim Uddin and 42 more

Abstract readMulticenter Study
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

52 authors.

Patricia B PavlinacDepartment of Global Health, University of Washington, Seattle, Washington,USA.ORCID 0000-0002-0051-9131
James A Platts-MillsDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Kirkby D TickellDepartment of Global Health, University of Washington, Seattle, Washington,USA.
Jie LiuDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Jane JumaCenter for Global Health Research, Kenya Medical Research Institute (KEMRI), Kenya.
Furqan KabirDepartment of Paediatrics and Child Health, Aga Khan University, Karachi,Pakistan.
Joseph NkezeCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.
Catherine OkoiMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul,The Gambia.
Darwin J OperarioDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Jashim UddinDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Shahnawaz AhmedInternational Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Dhaka,Bangladesh.
Pedro L AlonsoBarcelona Centre for International Health Research (CRESIB), Hospital Clínic, Universitat de Barcelona, Barcelona,Spain.
Martin AntonioMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul,The Gambia.
Stephen M BeckerScience Applications International Corporation (SAIC), Richmond, Virginia,USA.
Robert F BreimanDepartment of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
Abu S G FaruqueInternational Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Dhaka,Bangladesh.
Barry FieldsGlobal Disease Detection Division, Kenya Office of the US Centers for Disease Control and Prevention , Nairobi, Kenya.
Jean GratzDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Rashidul HaqueInternational Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Dhaka,Bangladesh.
Anowar HossainInternational Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Dhaka,Bangladesh.
M Jahangir HossainMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul,The Gambia.
Sheikh JarjuMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul,The Gambia.
Farah QamarDepartment of Paediatrics and Child Health, Aga Khan University, Karachi,Pakistan.
Najeeha Talat IqbalDepartment of Paediatrics and Child Health, Aga Khan University, Karachi,Pakistan.
Brenda KwambanaMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul,The Gambia.
Inacio MandomandoCentro de Investigação em Saúde da Manhiça, Maputo,Mozambique.
Timothy L McMurryPublic Health Sciences, University of Virginia, Charlottesville, Virginia,USA.
Caroline OchiengCenter for Global Health Research, Kenya Medical Research Institute (KEMRI), Kenya.
John B OchiengCenter for Global Health Research, Kenya Medical Research Institute (KEMRI), Kenya.
Melvin OchiengCenter for Global Health Research, Kenya Medical Research Institute (KEMRI), Kenya.
Clayton OnyangoGlobal Disease Detection Division, Kenya Office of the US Centers for Disease Control and Prevention , Nairobi, Kenya.
Sandra PanchalingamCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.
Adil KalamDepartment of Paediatrics and Child Health, Aga Khan University, Karachi,Pakistan.
Fatima AzizDepartment of Paediatrics and Child Health, Aga Khan University, Karachi,Pakistan.
Shahida QureshiDepartment of Paediatrics and Child Health, Aga Khan University, Karachi,Pakistan.
Thandavarayan RamamurthyNational Institute of Cholera and Enteric Diseases, Kolkata,India.
James H RobertsPublic Health Sciences, University of Virginia, Charlottesville, Virginia,USA.
Debasish SahaMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul,The Gambia.
Samba O SowCentre pour le Développement des Vaccins, Bamako,Mali.
Suzanne E StroupDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Dipika SurNational Institute of Cholera and Enteric Diseases, Kolkata,India.
Boubou TambouraCentre pour le Développement des Vaccins, Bamako,Mali.
Mami TaniuchiDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Sharon M TennantCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.
Anna RooseCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.
Deanna ToemaCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.
Yukun WuSanofi Pasteur, Swiftwater, Pennsylvania,USA.
Anita ZaidiBill and Melinda Gates Foundation, Seattle, Washington,USA.
James P NataroPublic Health Sciences, University of Virginia, Charlottesville, Virginia,USA.
Myron M LevineCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.
Eric R HouptDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia,USA.
Karen L KotloffCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland,USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundShigella 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.

methodsWe 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.

resultsCompared 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.

conclusionsA 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.

Indexed as

Dysentery, BacillaryShigellaVaccinesCase-Control StudiesChildDiarrheaHumansInfantPolymerase Chain ReactionVaccines

Identifiers

PMID33044509
PMCPMC8326551

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