Observational study on the clinical epidemiology of infectious acute encephalitis syndrome including Nipah virus disease, Bangladesh: BASE cohort study protocol

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Abstract Background Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh Acute Encephalitis Syndrome (BASE) cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, to inform the design of clinical trials for NiV and AES more broadly. Methods This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2,000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post-discharge. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day, and 90 days post-discharge. Additionally, a portion of the cerebrospinal fluid (CSF) collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory. Discussion By characterizing the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimizing the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Clinical trial number not applicable (this is an observational study)

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