Development of a new travellers’ diarrhoea clinical severity classification and its utility in confirming rifamycin-SV efficacy

Abstract Background travellers’ diarrhoea (TD) is frequently reported with incidence up to 40% in high-risk destinations. Previous studies showed that the number of loose stools alone is inadequate to holistically predict the severity of TD. To improve the prediction of prognosis and to optimize tre...

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Bibliographic Details
Published in:Journal of travel medicine 2023-10, Vol.30 (6)
Main Authors: DuPont, Herbert L, Almenoff, June S, Jamindar, Mansi S, Bortey, Enoch, Steffen, Robert
Format: Article
Language:English
Subjects:
Ciprofloxacin
Classification
Clinical trials
Diarrhea
Effectiveness
Original
Patients
Rifamycins
Signs and symptoms
Travellers
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Summary:Abstract Background travellers’ diarrhoea (TD) is frequently reported with incidence up to 40% in high-risk destinations. Previous studies showed that the number of loose stools alone is inadequate to holistically predict the severity of TD. To improve the prediction of prognosis and to optimize treatments, a simple risk-based clinical severity classification has been developed. Methods pooled baseline data of signs and symptoms and number of loose stools from 1098 subjects enrolled in two double-blind Phase 3 trials of rifamycin-SV were analyzed with correlation, multiple correspondence analyses, prognostic factor criteria, and Contal and O’Quigley method to generate a TD severity classification (mild, moderate and severe). The relative importance of this classification on resolution of TD was assessed by Cox proportional model hazard model on the time to last unformed stool (TLUS). Results the analysis showed that TLUS were longer for the severe [hazard ratio (HR) 0.24; P 
ISSN:1195-1982
1708-8305
DOI:10.1093/jtm/taad043