An observational study in Dengue, Dengue Hemorrhagic Fever and Intestinal Disease, sponsored by University of Oxford. Recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by University of Oxford · Observational
Dengue infections are imposing an increasing global burden of disease, particularly in tropical countries such as Bangladesh. The World Health Organization (WHO) has identified Dengue virus as a priority pathogen for the development of medical counter measures because of the high risk of it causing a Public Health Emergency of Intenational Concern (PHEIC). Warning signs for severe dengue, associated with mortality, include gastrointestinal features including abdominal pain, vomiting, and diarrhoea. Multiple alterations may occur in in the gastrointestinal tract that could lead to damaging of the gastrointestinal wall and gut leakage, the translocation of gut metabolites into the bloodstream. Study team hypothesize that gut leakage initiates inflammatory processes underlying the further development of severe dengue, including features associated with plasma leakage.
This study aims to investigate intestinal barrier dysfunction (gut leakage) in dengue infection by detecting the translocation of gut-derived bacteria and their products (Lipopolysaccharides, LPS binding protein, sCD14, I-Fatty Acid Binding Protein) into the bloodstream. Study team will recruit hospitalized adult dengue patients (18 years and older) presenting with warning signs or severe disease in a tertiary care public hospital at Chattogram, Bangladesh. Circulating biomarkers indicative of gut permeability and microbial translocation will be measured to assess their presence and association with disease severity.
Abdominal ultrasonography will be performed to characterize gastrointestinal alterations and determine their correlation with biochemical markers of gut leakage and clinical severity. In addition, study team will analyze the gut bacteriome from stool/ rectal swab of these patients to explore whether dengue infection induces compositional changes in intestinal microbiota and whether such alterations are linked to gut leakage or disease progression.
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's planned enrollment of 190 is below the median of 667 across 13 observational studies indexed under Severe Dengue.
Browse Severe Dengue studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Compared within Severe Dengue, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dengue. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult (≥18 years) male and non-pregnant female patients with confirmed dengue (positive NS1 antigen and/or IgM) admitted to the Department of Medicine, Chittagong Medical College Hospital will be recruited. Blood biomarkers will be collected at enrollment for all patients. Those initially classified as non-severe dengue will have no repeat sampling unless they progress to severe disease, in which case a second sample will be obtained within 24 hours. Serum ALT and blood culture will be performed on day 7 of illness. Stool samples will be collected on day 7 from 100 patients for gut microbiota analysis.
Additionally, 10 healthy adult participants (5 male, 5 female) will be recruited from patient attendants. They will undergo a single visit for baseline biomarker sampling and POCUS, serving as healthy controls for comparison.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Dengue participants
Healthy participants
Exclusion Criteria:
Dengue participants
Healthy participants
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled dengue patients will have blood biomarkers at enrolment whether they present with non-severe or severe dengue. If participant enrolled as non-severe and do not progress to severe dengue, they will be no second test for biomarkers but if they developed clinical feature of severity, a second biomarker sample will be collected within 24 hours of developing clinical severity. S ALT and Blood culture will be performed on day 7 of illness for all dengue patients. Stool will be collected on day 7 of illness from 100 patients for testing gut microbiota.
All enrolled dengue patients will have blood biomarkers at enrolment whether they present with non-severe or severe dengue. If participant enrolled as non-severe and do not progress to severe dengue, they will be no second test for biomarkers but if they developed clinical feature of severity, a second biomarker sample will be collected within 24 hours of developing clinical severity. S ALT and Blood culture will be performed on day 7 of illness for all dengue patients. Stool will be collected on day 7 of illness from 100 patients for testing gut microbiota.
These participants will undergo only one study visit for baseline biomarker sampling, baseline POCUS and will not undergo follow-up. Their results will serve as healthy control reference values for comparison with biomarker findings in dengue patients.
Level of gut leakage marker in blood and gastrointestinal findings in POCUS
Time frame: On enrollment, day of development of severity if non severe at enrolment, up to 28 days
Document clinical events occurred in dengue patients
Demographic: Age, gender, BMI Clinical: respiratory rate, blood pressure, heart rate, ascites, pleural effusion, any major bleeding, GCS
Time frame: Through study completion, an average of 28 days
Document clinical events occurred in dengue patients
For mSOFA: SpO2, FiO2
Time frame: Day of enrolment/ 4th or day 7 of illness
Level of I-FABP Level of LPS, Level of LBP, Level of sCD14, Positive Blood culture
Time frame: On enrollment in all cases, if clinical severity occur in initial non-severe group, 24 hours within developing severity
Detectable fluid collection in abdomen, loss of haustration, loss of normal multi-layered appearance
Time frame: Baseline (within 24 hours of enrollment) and at the time of first development of clinical severity, assessed from enrollment until clinical severity occurs, hospital discharge, death, or up to 7 days of hospitalization, whichever occurs first.
Measurement of gall bladder wall thickness, intestinal wall thickness
Time frame: Baseline (within 24 hours of enrollment) and at the time of first development of clinical severity, assessed from enrollment until clinical severity occurs, hospital discharge, death, or up to 7 days of hospitalization, whichever occurs first.
Alteration of gut microbiota
Time frame: Day seven of illness
Organ failure
Time frame: Through study completion, an average of 28 day
Development of shock
Time frame: Through study completion, an average of 28 day
Plan to share: Yes — Participant data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future. Datasets will be de-identified to ensure patient privacy and confidentiality
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jan 2027, 5 months after the start.
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