Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
13/12/2007
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 Jeremy Farrar

ORCID ID

Contact details

Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 8 836 2225
jeremyjf@hcm.vnn.vn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

061330

Study information

Scientific title

Acronym

DL Study

Study hypothesis

We have started to see new cases of H5N1 infection. Five new cases confirmed in the last week all from different provinces of southern Viet Nam suggesting widespread (and therefore difficult to control) distribution of the virus. We suspect that this epidemic will prove more extensive than 2004. There is more than 80% mortality in the confirmed cases and most severe cases have been in children and teenagers. All patients are managed in a dedicated ward with barrier nursing and medical care. All patients are treated with oseltamivir for five days. Some patients have been given steroids some have not. There is no evidence on which to guide treatment, drugs, doses or duration. We have documented massive cytokine release in the patients from 2004. Our TaqMan real time Polymerase Chain Reaction (PCR) results are available within 24 hours of a sample being taken.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Avian Influenza

Intervention

Dexamethasone

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamethasone

Primary outcome measures

Mortality

Secondary outcome measures

1. Duration of ventilation
2. Duration of supplemental oxygen
3. Duration of hospitalisation
4. Viral load in clinical specimens
5. Cytokine levels
6. Adverse effects

Overall trial start date

01/01/2005

Overall trial end date

31/12/2006

Reason abandoned

No patients with H5N1 in Viet Nam since August 2005, only four patients recruited in total. Data being analysed.

Eligibility

Participant inclusion criteria

1. Patients with confirmed TaqMan Influenza A positive, or H5N1 PCR
2. Patients with history of clear close exposure to sick poultry, Chest X-Ray changes consistent with H5N1, low white count and strong clinical suspicion of H5N1 infection

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

4 - recruitment terminated as not enough patients

Participant exclusion criteria

No consent

Recruitment start date

01/01/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 061330)

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