Condition category
Infections and Infestations
Date applied
24/07/2008
Date assigned
21/10/2008
Last edited
21/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Walter Bob Taylor

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTU04DXAPR08

Study information

Scientific title

Acronym

Study hypothesis

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

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)

Study design

Observational descriptive study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2008

Overall trial end date

30/01/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

200

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/08/2008

Recruitment end date

30/01/2009

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Oxford University Clinical Research Unit
Hanoi
-
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 077078)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes