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.
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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
Аннотация
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.