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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN92443272

Enrollment

200

Registered

2008-10-21

Start date

2008-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue fever Infections and Infestations Dengue fever [classical dengue]

Interventions

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 s

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not comply with the above inclusion criteria.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026