Dengue infection in adults and children in Hanoi: a descriptive clinical and immunological study

ISRCTN	ISRCTN92443272
DOI	https://doi.org/10.1186/ISRCTN92443272
Protocol serial number	CTU04DXAPR08
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 077078)

Submission date: 24/07/2008
Registration date: 21/10/2008
Last edited: 21/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Walter Bob Taylor
Scientific

Oxford University Clinical Research Unit
National Institute of Infectious and Tropical Diseases (NIITD)
78 Giai Phong Street
Hanoi
-
Viet Nam

Study information

Primary study design	Observational
Study design	Observational descriptive study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title
Study objectives	We hypothesise that factors other than enhancing antibody level affect viral load and dengue severity. To identify such factors we will focus on patients with symptomatic primary dengue who by definition lack pre-existing dengue antibodies.
Ethics approval(s)	1. The Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) gave approval on the 25th June 2008 (ref: 26/08) 2. Pending as of 25/07/2008 from the NIITD Ethical Committee (Viet Nam)
Health condition(s) or problem(s) studied	Dengue fever
Intervention	Because dengue is seasonal, most of the dengue patients will be recruited over a period of some 6 months, from May to September. During this time, patients will be recruited and then followed up. If some patients have a persistent abnormality that may be dengue related, e.g. evidence of reduced cardiac function, they will be followed up until either their abnormality stabilises or for at least one year. Depending on recruitment, the study may be extended to cover a second dengue season. Descriptive analyses of the endpoints will consist of proportions for categorical data and means (SD, 95% CIs) and/or median (inter-quartile and full ranges) for continuous data supplemented by graphical displays where relevant. Simple correlations (Pearson's correlation coefficient or Spearman's rho) will be made between continuous data, e.g. cytokine and complement concentrations. Comparative analyses will be between: 1. Patients who develop severe dengue (DHF/DSS) versus those who do not, and 2. Patients with 10 and 20 infections For categorical data, the comparisons will be by chi squared. For continuous data, the student's 't' test for normally distributed data or Mann Whitney U tests for skewed data. Other analyses: 1. Full blood count, differential white cell count 2. Clotting studies - prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen and d-dimers. Antithromin III, protein C and S may be done later on stored plasma. 3. Sodium, potassium, urea, creatinine, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), total creatine kinase (CK), creatine kinase myocardial bands (CKmb) fraction, cardiac troponins, total bilirubin, total protein, albumin 4. Quantitative protein electrophoresis 5. Urine analysis 6. Radiology 7. Electrocardiograms (ECGs) 8. Echocardiograms (ECHO) 9. Spirometry (for lung function) 10. Virology studies
Intervention type	Other
Primary outcome measure(s)	1. Proportions of patients with 10 (Immunoglobulin M and Immunoglobulin G ratio [IgM:IgG] greater than or equal to 1.8:1) or 20 (IgM:IgG ratio less than 1.8:1) infections* 2. Proportions of patients who develop severe dengue (DHF/DSS) * as noted in section 4.3 of the protocol; these definitions may change As it is a descriptive study the data will be analysed once all data have been collected. There are no timepoints for interim analyses.
Key secondary outcome measure(s)	1. The ECG abnormalities of rate, rhythm and ECG intervals (PR, QRS, QT) 2. Cardiac function (echocardiogram) - ejection fraction (%), cardiac index (L/min/m^2) and rate corrected velocity of circumferential ventricular fibre shortening adjusted for left ventricular wall stress (kilodyne/cm^2) 3. Lung volumes: forced vital capacity (FVC) in litres, forced expiratory volume in one second (FEV1) in litres/s, and the FEV1/FVC ratio 4. The proportions of patients with pleural effusions and ascites 5. Dengue viral load at baseline and over time 6. NS1 concentration at baseline and over time 7. Cytokine, complement and anti-dengue neutralising antibody concentrations at baseline and over time 8. Fractional clearances of albumin and other plasma proteins As it is a descriptive study the data will be analysed once all data have been collected. There are no timepoints for interim analyses.
Completion date	30/01/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. A patient of any age, including pregnant women, with suspected dengue infection using the World Health Organization (WHO) criteria below: 1.1. History of fever and two or more of the following: 1.1.1. Headache 1.1.2. Retro-orbital pain 1.1.3. Myalgia 1.1.4. Arthralgia 1.1.5. Rash 1.1.6. Haemorrhagic manifestation 1.1.7. Leukopaenia 2. Informed consent signed by the patient or parent/guardian
Key exclusion criteria	Does not comply with the above inclusion criteria.
Date of first enrolment	01/08/2008
Date of final enrolment	30/01/2009

Locations

Countries of recruitment

Viet Nam

Study participating centre

Oxford University Clinical Research Unit

Hanoi
-
Viet Nam

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes