Enhancing dermatological diagnoses in patients with skin diseases at the National Institute for Infectious and Tropical Diseases in Hanoi
| ISRCTN | ISRCTN17146141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17146141 |
| Protocol serial number | ctu01dtfec08 |
| Sponsor | University of Oxford (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 077078) |
- Submission date
- 16/07/2008
- Registration date
- 17/07/2008
- Last edited
- 16/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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
The Oxford University Clinical Research Unit (OUCRU)
National Institute of Infectious and Tropical Diseases (NIITD)
78 Giai Phong Street
Hanoi
-
Viet Nam
| Phone | +84 4 576 4320 |
|---|---|
| btaylor@oucru.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | This is a pilot study without a formal sample size calculation. |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | The rationale of this protocol is to begin the first steps of skin research at National Institute for Infectious and Tropical Diseases in Hanoi. |
| Ethics approval(s) | Ethics approval received from the Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) on the 20th June 2008 (ref: 12/08). Ethics approval pending as of 16/07/2008 from the ethics committee of the National Institute of Infectious and Tropical Diseases (NIITD). |
| Health condition(s) or problem(s) studied | Dermatology/skin rashes |
| Intervention | This pilot study is not randomised or controlled. Potential study participants will be patients with a rash of unknown cause of with a suspected rash of one of the diseases of interest. For the patients in whom a skin biopsy is thought to be clinically important, a discussion will first take place between the research team and the treating physicians. If it is decided that a skin biopsy is indicated, the patient will be told about the study and, if interested, a member of the research team will go through the informed consent process. Skin biopsies will be divided and placed in suitable media for further investigation. This will include: 1. 10% buffered formalin for routine histology and polymerase chain reaction (PCR) 2. Michel's solution for immunoflourescence 3. Viral transport medium for viral culture 4. Sterile container for bacterial or fungal culture 5. Glutaldehyde for electron microscopy If a skin scraping is done, it will be sent for microscopy (KOH stain) and/or fungal culture. Fluid from vesicles may be sent to the laboratory for herpes PCR. Basic clinical history history, past medical history, drug history, previous skin diseases, physical examination, including the skin rash distribution, and the results of routine investigations will also be performed. |
| Intervention type | Other |
| Primary outcome measure(s) |
Clinical diagnosis |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients admitted to the NIITD of any age, either sex 2. Obtaining informed consent 3. Any patient with an undiagnosed rash 4. Any patient with suspected Streptococcus suis, Penicillium marneffei, typhus or dengue |
| Key exclusion criteria | An active bleeding tendency |
| Date of first enrolment | 31/07/2008 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
The Oxford University Clinical Research Unit (OUCRU)
Hanoi
-
Viet Nam
-
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
