A double blind study of dexamethasone for the treatment of H5N1 Avian Influenza
| ISRCTN | ISRCTN07092892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07092892 |
| Protocol serial number | 061330 |
| Sponsor | University of Oxford (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 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
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 |
|---|---|
| jeremyjf@hcm.vnn.vn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone |
| Primary outcome measure(s) |
Mortality |
| Key secondary outcome measure(s) |
1. Duration of ventilation |
| 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 sample size at registration | 4 |
| 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
5
Viet Nam
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
