Dengue infection in adults and children in Hanoi: a descriptive clinical and immunological study
| ISRCTN | ISRCTN92443272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92443272 |
| Secondary identifying numbers | CTU04DXAPR08 |
- 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
Scientific
Oxford University Clinical Research Unit
National Institute of Infectious and Tropical Diseases (NIITD)
78 Giai Phong Street
Hanoi
-
Viet Nam
Study information
| Study design | Observational descriptive study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 outcome measures | 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. |
| Overall study start date | 01/08/2008 |
| Completion date | 30/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
-
Viet Nam
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 077078)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
