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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Consensus Report on Shigella Controlled Human Infection Model: Clinical Endpoints
Clinical Infectious Diseases, Volume 69, Year 2019
Notification
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Description
The Shigella controlled human infection model (CHIM) is valuable for assessing candidate Shigella vaccine efficacy and potentially accelerating regulatory approval. The Shigella CHIM is currently being conducted at 3 sites in the United States using Shigella flexneri 2a strain 2457T and Shigella sonnei strain 53G. Shigellosis can present variably as watery diarrhea alone or with dysentery, and can be accompanied by manifestations including fever, abdominal cramps, tenesmus, and malaise. For comparability, it is important to harmonize the primary clinical endpoint. An expert working group was convened on 2 February 2018 to review clinical data from Shigella CHIM studies performed to date and to develop a consensus primary endpoint. The consensus endpoint enabled "shigellosis" to present as severe diarrhea or moderate diarrhea or dysentery. The latter 2 criteria are met when concurrent with fever of 38.0°C and/or vomiting, and/or a constitutional/enteric symptom graded at least as "moderate" severity. The use of a blinded independent committee to adjudicate the primary endpoint by subject was also regarded as important. As safety of volunteers in challenge studies is of paramount importance and treatment timing can affect primary outcomes, a standard for early antibiotic administration was established as follows: (1) when the primary endpoint is met; (2) if a fever of ≥39.0°C develops; or (3) if the study physician deems it appropriate. Otherwise, antibiotics are given at 120 hours postinfectious challenge. The working group agreed on objective and subjective symptoms to be solicited, and standardized methods for assessing subject-reported severity of symptoms. © 2019 The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.
Authors & Co-Authors
MacLennan, Calman Alexander
Unknown Affiliation
Riddle, Mark S.
United States, Bethesda
Uniformed Services University of the Health Sciences
Chen, Wilbur H.
United States, Baltimore
University of Maryland School of Medicine
Talaat, Kawsar R.
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Jain, Varsha K.
Unknown Affiliation
Bourgeois, August Louis
United States, Washington, D.c.
Path
Frenck, Robert W.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Kotloff, Karen L.
United States, Baltimore
University of Maryland School of Medicine
Porter, Chad K.
United States, Silver Spring
Naval Medical Research Center
Statistics
Citations: 20
Authors: 9
Affiliations: 6
Identifiers
Doi:
10.1093/cid/ciz891
ISSN:
10584838