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 AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.
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 2000 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 enrolment. 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 enrollment. Additionally, a portion of the cerebrospinal fluid 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.
The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.
Not applicable (this is an observational study).
The COVID-19 pandemic’s unprecedented nature has exposed significant vulnerabilities in most public health systems and highlighted the importance of coordinated responses across various levels of government. A global debate emerged on the types of health measures necessary to curb the rapid spread of contagious and/or lethal diseases. However, some of these measures involved restricting individual rights, raising significant ethical, legal and public health questions. The protocol of this systematic review aims to address a critical gap in the literature by analysing how Public Health Surveillance services worldwide implemented compulsory right-restricting measures during the COVID-19 pandemic, and what impacts these measures had on public health outcomes and individual rights.
This protocol focuses on studies about right-restricting measures enacted by Public Health Surveillance services during the COVID-19 pandemic. It will be unrestrictive as to period (starting in 2019, when the outbreak was identified), language or publication status in a preliminary stage. It will include only peer-reviewed publications, discarding opinion articles, editorials, conference papers and non-peer-reviewed publications. Considering the PICo strategy, the research question of this systematic review can be formulated as follows: Problem—right-restricting measures enacted by Public Health Surveillance services; Interest—implementation modalities and impacts on individual rights and public health outcomes; Context—COVID-19 pandemic. This protocol will use the following databases: Pubmed, Cochrane/CENTRAL, Embase, Scopus and Web of Science. Considering the various measures that may have been adopted, the following categories of analysis will be used: (i) Public Health Surveillance as a field, (ii) the various specific areas of Health Surveillance, (iii) law enforcement, (iv) right-restricting measures and consent, (v) interactions between right-restricting measures and routine Public Health Surveillance functions, (vi) differences between countries and (vii) Health Surveillance lessons learnt from the COVID-19 pandemic. These categories are not strictly mutually exclusive; however, each study will be assigned to the category most aligned with its primary focus. To ensure the validity and reliability of findings, each study will have its risk of bias assessed at both the study and outcome levels.
Patients and the public were not involved in the design, conduct, reporting or dissemination plans of this systematic review. The results will be presented in one or more articles to be submitted to scientific journals and may also be presented at scientific conferences and to public policy makers.
This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 20 November 2024 (registration number CRD42024613039).
Bloodstream infection (BSI) due to multidrug-resistant Gram-negative bacilli is a serious global health problem that has a profound impact on severely immunosuppressed neutropenic haematological patients. Prompt institution of appropriate antimicrobial therapy is crucial for improving outcomes in these patients, and in an era of multidrug resistance, antimicrobial stewardship programmes are mandatory. Blood cultures, the current gold standard for the diagnosis of BSI, present two main drawbacks: the prolonged time to results and their low sensitivity, especially if the patient has received antimicrobial treatment before blood extraction. The aim of this study is to determine whether a molecular technique, the BioFire FilmArray Blood Culture Identification 2 (BCID2) panel, achieves higher sensitivity and specificity than conventional blood cultures for the microbiological diagnosis of BSI in haematological patients with febrile neutropenia.
This multicentre, prospective, observational study will be conducted at three reference university hospitals in Spain. The population will comprise haematological patients scheduled to undergo diagnostic blood cultures as standard care for the microbiological diagnosis of the febrile neutropenia episode. The BioFire FilmArray panel will be performed in patients with positive blood cultures at the time of blood culture positivity and in patients with negative blood cultures at 48 hours of incubation. The primary endpoint will be the sensitivity and specificity of the BioFire FilmArray BCID2 panel compared with conventional blood cultures. The secondary endpoints will be this same comparison in the subgroup of patients with recent (
The study protocol has been approved by the Clinical Research Ethics Committee at Bellvitge Hospital (reference number ICPS029/22) and the Institutional Review Boards at each participating site. All patients’ personal data will be processed, disclosed and transferred in accordance with Organic Law 3/2018 of 5 December 2018 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016. All data will be collected, stored and processed anonymously. Results will be reported at conferences and in peer-reviewed publications regardless of whether the hypothesis is demonstrated. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors.
The aim of this study is to assess the impact of the BCID2 panel on the diagnostic yield of BSI in haematological patients with febrile neutropenia. Unlike previous studies, which focused on patients with documented BSI, our research will include all patients with febrile neutropenia.