A double blind study of dexamethasone for the treatment of H5N1 Avian Influenza

ISRCTN	ISRCTN07092892
DOI	https://doi.org/10.1186/ISRCTN07092892
Secondary identifying numbers	061330

Submission date: 22/07/2005
Registration date: 22/07/2005
Last edited: 13/12/2007

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 Jeremy Farrar
Scientific

Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam

Phone	+84 8 836 2225
Email	jeremyjf@hcm.vnn.vn

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	DL Study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Avian Influenza
Intervention	Dexamethasone
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethasone
Primary outcome measure	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 study start date	01/01/2005
Completion date	31/12/2006
Reason abandoned (if study stopped)	No patients with H5N1 in Viet Nam since August 2005, only four patients recruited in total. Data being analysed.

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	4 - recruitment terminated as not enough patients
Key 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
Key exclusion criteria	No consent
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Viet Nam

Study participating centre

Hospital for Tropical Diseases

Ho Chi Minh City
5
Viet Nam

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Website	http://www.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

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

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