Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
NCT06822907
Acute Febrile Illness, Bacterial Infections
Saint-Etienne, France
View Trial DetailsNCT Number: NCT04629053
This prospective multi-site observational study aims to describe causes and clinical outcomes of acute febrile illness as well as host biomarkers in patients aged >28 days residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses (≤ 14 days duration) to participating health facilities.
This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
Interested in participating?
Request Info29 day and older
All sexes
Observational
Building Resources Across Communities (BRAC), Dhaka, Bangladesh
The majority of people in low- and middle-income countries (LMICs) in South and Southeast Asia live in rural areas. These people are some of the poorest in the region and the exact health issues which concern them have not been well defined, in that they have not been fully studied. Despite this lack of data, there are indications that disease of an infectious aetiology, 'febrile illness,' in particular in the tropics, still accounts for significant morbidity and mortality. This is in contrast to higher-income countries.
The South and Southeast Asian Community-based Trials Network in Rural Febrile Illness project (SEACTN RFI) aims to better understand and quantify the burden of febrile illness, the aetiological causes and the manner in which it affects the people of the area, all on a scale which has not been attempted before. It will collect information to help better understand and predict these outcomes based on a multitude of factors, which will form the basis for interventions within the network in the future. The initial study will be observational, as the current understanding of the local health issues and the health systems in these areas is insufficient to know how best to intervene.
In a separate work package, Work Package A (WP-A), the investigators will be collecting data from within the participating SEACTN communities through village health workers (VHWs) and local health facilities on the incidence, causes and outcomes of febrile illness in these areas.
In Work Package B (WP-B) will recruit patients seeking care at higher level facilities than the WP-A VHWs and health centres. These patients are likely to be more severely ill, in order to obtain a more thorough understanding of the causes and burden of febrile illness in these areas. A broader range of specimens, including venous blood samples and respiratory specimens will be collected. In-depth diagnostic testing including blood cultures, serological assays, pathogen molecular diagnostics, host biomarker assays, and validation of pathogen-blind next generation sequencing approaches will be conducted. The data from WP-A gathered in the community complemented by the WP-B data from higher level health facilities in the same regions will provide a rich understanding of the causes, incidence and outcomes of febrile illness in these areas. These data will be analysed using advanced statistical methodology to create electronic decision-support tools (eDSTs) to aid VHWs in their assessment, triage and treatment of patients. These and other relevant interventions will later be trialled across the SEACTN villages.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Samples collected over approximately 1 month
Prevalence of a range of pathogens identified from febrile patients, analysed by region and participant age group
Time frame: Approximately 1 month
Recovery status e.g. full recovery, partial recovery, deterioration, and death at specified time points up to 28 days from enrolment
Time frame: Samples collected over approximately 1 month
The area under the curve, sensitivity and specificity of host biomarkers and other predictors to identify bacterial infections and to predict severe outcomes.
Contact information is provided by the study sponsor or research team.
Rusheng Chew, Dr.
CONTACT
Yoel Lubell, Prof.
CONTACT
University of Oxford
Other
Determining the Causes and Outcomes of Febrile Illness in Health Care Facilities in Rural South and Southeast Asia, as Part of the South and Southeast Asian Community-based Trials Network (SEACTN). Work Package B (WP-B).
Acronym: SEACTN-WP-B
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06822907
Acute Febrile Illness, Bacterial Infections
Saint-Etienne, France
View Trial DetailsNCT04878549
Acute Febrile Illness, Bacterial Infections
Vellore, India
View Trial DetailsNCT07205575
Acute Febrile Illness, Bacterial Infections
Jinan, Shandong, China
View Trial DetailsNCT04081051
Acute Febrile Illness
Nanoro, Burkina Faso
View Trial Details