Condition category
Skin and Connective Tissue Diseases
Date applied
16/07/2008
Date assigned
17/07/2008
Last edited
16/10/2008
Prospective/Retrospective
Prospectively 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

The Oxford University Clinical Research Unit (OUCRU)
National Institute of Infectious and Tropical Diseases (NIITD)
78 Giai Phong Street
Hanoi
-
Viet Nam
+84 4 576 4320
btaylor@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ctu01dtfec08

Study information

Scientific title

Acronym

Study hypothesis

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

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).

Study design

This is a pilot study without a formal sample size calculation.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Clinical diagnosis

Secondary outcome measures

No secondary outcome measures

Overall trial start date

31/07/2008

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

100 patients

Participant exclusion criteria

An active bleeding tendency

Recruitment start date

31/07/2008

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Viet Nam

Trial participating centre

The Oxford University Clinical Research Unit (OUCRU)
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